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B Braun Medical Inc FDA Recalls

273 recalls on file across drugs, devices, 21 of them Class I and 240 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical IncClass IAug 19, 2026Presence of Particulate Matter: particulate matter identifie
Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-35Class IAug 12, 2026Presence of Particulate matter.
Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025Class IIAug 4, 2026Specific lots of Discofix Stopcock Sets recalled due to an i
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), BClass IMay 6, 2026These procedure kits contain Bupivacaine Hydrochloride in De
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M CClass IMay 6, 2026These procedure kits contain Bupivacaine Hydrochloride in De
Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867Class IMay 6, 2026These procedure kits contain Bupivacaine Hydrochloride in De
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0Class IApr 28, 2026Presence of Particulate Matter.
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: Class IIApr 2, 2026Lack of Assurance of Sterility; potential for leakage from t
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, Class IIApr 2, 2026Lack of Assurance of Sterility; potential for leakage from t
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC:Class IIApr 2, 2026Lack of Assurance of Sterility; potential for leakage from t
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 1801Class IIApr 2, 2026Lack of Assurance of Sterility; potential for leakage from t
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.Class IMar 19, 2026Potential for the accumulation of small air bubbles in the a
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.Class IMar 19, 2026Potential for the accumulation of small air bubbles in the a
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.Class IMar 19, 2026Potential for the accumulation of small air bubbles in the a
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.Class IMar 19, 2026Potential for the accumulation of small air bubbles in the a
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.Class IMar 19, 2026Potential for the accumulation of small air bubbles in the a
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096Class IMar 19, 2026Potential for the accumulation of small air bubbles in the a
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/AClass IIFeb 2, 2026The potential for the needle tip to be dull/blunt, difficult
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product DeClass IIFeb 2, 2026The potential for the needle tip to be dull/blunt, difficult
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software VersionClass IIFeb 2, 2026The potential for the needle tip to be dull/blunt, difficult
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: Class IIJan 29, 2026B. Braun was notified by our supplier, Ferndale Laboratories
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 SoftwaClass IIJan 29, 2026B. Braun was notified by our supplier, Ferndale Laboratories
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Class IIJan 29, 2026B. Braun was notified by our supplier, Ferndale Laboratories
Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software VClass IIJan 29, 2026B. Braun was notified by our supplier, Ferndale Laboratories
Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 SoClass IIJan 29, 2026B. Braun was notified by our supplier, Ferndale Laboratories
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software VeClass IIJan 29, 2026B. Braun was notified by our supplier, Ferndale Laboratories
Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: Class IIJan 29, 2026B. Braun was notified by our supplier, Ferndale Laboratories
Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Class IIJan 29, 2026B. Braun was notified by our supplier, Ferndale Laboratories
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusomatClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusomatClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaceClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space LarClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space LaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaceClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaceClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusomatClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusomatClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaceClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusomatClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space LClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaceClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusomatClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusomatClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space LaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusomatClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaceClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaceClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space LaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusomatClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
B.BRAUN utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space LarClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaceClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space LClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
CARESAFE utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space LaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaceClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space LarClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpaClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space LarClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's InfusClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat SpacClass IIOct 29, 2025Potential for backflow of medication from secondary (piggyba
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M20Class ISep 30, 2025The potential for micro-air bubbles observed in the bloodlin
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 1Class IISep 18, 2025Potential for the lid of the catheter connector to be in the
PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERClass IISep 18, 2025Potential for the lid of the catheter connector to be in the
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Class IISep 18, 2025Potential for the lid of the catheter connector to be in the
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged aClass IISep 18, 2025Potential for the lid of the catheter connector to be in the
Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JClass IISep 18, 2025Potential for the lid of the catheter connector to be in the
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 1Class IISep 18, 2025Potential for the lid of the catheter connector to be in the
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and Class IISep 18, 2025Potential for the lid of the catheter connector to be in the
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga.Class IISep 18, 2025Potential for the lid of the catheter connector to be in the
ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN Class IISep 18, 2025Potential for the lid of the catheter connector to be in the
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged anClass IISep 18, 2025Potential for the lid of the catheter connector to be in the
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged aClass IISep 18, 2025Potential for the lid of the catheter connector to be in the
Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. xClass IISep 18, 2025Potential for the lid of the catheter connector to be in the
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY.Class IISep 18, 2025Potential for the lid of the catheter connector to be in the
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., BethlehemClass IIAug 26, 2025Lack of Assurance of Sterility- Potential for fluid leakage
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.Class IIAug 26, 2025Lack of Assurance of Sterility- Potential for fluid leakage
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC Class IAug 18, 2025Presence of Particulate Matter
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDClass IAug 18, 2025Presence of Particulate Matter.
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, Class IIAug 4, 2025Lack of Assurance of Sterility; potential for fluid leakage
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose containeClass IIAug 4, 2025Lack of Assurance of Sterility; potential for fluid leakage
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.Class IJul 9, 2025Label is incorrect. The product label indicates that the dev
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx onlClass IIJun 16, 2025Lack of assurance of sterility: pinholes, within the finger
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. BraClass IIMar 31, 2025Presence of Particulate Matter
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.Class IIFeb 17, 2025Increased risk for valve housing detachment causing leakage.
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal Class IIDec 4, 2024Incorrect catheter connector within the kit resulting in ina
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodiClass IIAug 15, 2024Incomplete insertion of the patient connector of the Stream
STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during Class IIAug 15, 2024Incomplete insertion of the patient connector of the Stream
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodiClass IIAug 15, 2024Incomplete insertion of the patient connector of the Stream
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haeClass IIAug 15, 2024Incomplete insertion of the patient connector of the Stream
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. ModelClass IIAug 15, 2024Incomplete insertion of the patient connector of the Stream
STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during Class IIAug 15, 2024Incomplete insertion of the patient connector of the Stream
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodClass IIAug 15, 2024Incomplete insertion of the patient connector of the Streaml
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog NumberClass IIAug 8, 2024Potential for product leakage from the Spin Lock Connector o
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050UClass IAug 7, 2024Extension of previous recall RES 92978. Pumps have the poten
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-0Class IJul 24, 2024Presence of Particulate Matter
Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV)Class IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration oClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administratiClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) adClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration oClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) Class IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) admClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) aClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) Class IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administraClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV)Class IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) aClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administraClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) Class IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) admClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) aClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) Class IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) aClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) adminClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV)Class IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) adminiClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) aClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IVClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) admClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) Class IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) adClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administratioClass IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV)Class IIJun 17, 2024Potential for the backcheck valve to malfunction, resulting
Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: PClass IIJun 14, 2024Perfusor Space Syringe Pump's instructions for use previousl
Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product DescriptionClass IIJun 14, 2024Perfusor Space Syringe Pump's instructions for use previousl
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U SoftwarClass IIJun 14, 2024Perfusor Space Syringe Pump's instructions for use previousl
Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product DClass IIJun 14, 2024Perfusor Space Syringe Pump's instructions for use previousl
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U ProClass IIJun 14, 2024Perfusor Space Syringe Pump's instructions for use previousl
Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502Class IIMay 17, 2024The devices are labeled "not made with DEHP" or the DEHP fre
Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278Class IIMay 17, 2024The devices are labeled "not made with DEHP" or the DEHP fre
Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.Class IIMay 17, 2024The devices are labeled "not made with DEHP" or the DEHP fre
Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260Class IIMay 17, 2024The devices are labeled "not made with DEHP" or the DEHP fre
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7Class IIMar 22, 2024Lack of assurance of sterility: bags have the potential to l
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc.,Class IIMar 6, 2024Lack of assurance of sterility: pinholes, within the blue la
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL GlassClass IIJan 22, 2024Kits should contain Filter Straws with Standard Luer Connect
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of deviceClass IIJan 22, 2024Kits should contain Filter Straws with Standard Luer Connect
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 3Class INov 1, 2023In affected products, the tubing outer diameter may vary in
30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.Class IISep 26, 2023Devices may leak as a result of a manufacturing issue. Leaka
THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-Class IISep 26, 2023Devices may leak as a result of a manufacturing issue. Leaka
30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.Class IISep 26, 2023Devices may leak as a result of a manufacturing issue. Leaka
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.Class IISep 26, 2023Devices may leak as a result of a manufacturing issue. Leaka
FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution contaClass IISep 26, 2023Devices may leak as a result of a manufacturing issue. Leaka
SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.Class IISep 26, 2023Devices may leak as a result of a manufacturing issue. Leaka
AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.Class IISep 26, 2023Devices may leak as a result of a manufacturing issue. Leaka
TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.Class IISep 26, 2023Devices may leak as a result of a manufacturing issue. Leaka
BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.Class IISep 26, 2023Devices may leak as a result of a manufacturing issue. Leaka
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump SystemClass ISep 21, 2023Upstream occlusion alarm may sound when no occlusion exists,
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump SystemClass ISep 21, 2023Upstream occlusion alarm may sound when no occlusion exists,
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dosClass IIAug 7, 2023The sterile blister packaging may be damaged, and sterility
B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metereClass IIAug 7, 2023The sterile blister packaging may be damaged, and sterility
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDClass IIIAug 2, 2023Labeling: Not Elsewhere Classified - the description, warnin
Perifix¿ / Epidural anesthesia set, medicatedClass IIJul 31, 2023Product may be mislabeled with an incorrect lid stock label.
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-352Class IIJul 5, 2023Lack of assurance of sterility: bags have the potential to l
Perifix¿ / Epidural anesthesia kit (10 count carton)Class IIJun 5, 2023Kits were assembled with the incorrect Filter Straw.
Design Options¿ / Epidural anesthesia kit (10 count carton)Class IIJun 5, 2023Kits were assembled with the incorrect Filter Straw.
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B.Class IIMay 9, 2023Subpotent: Low anti-factor IIa Potency.
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.BClass IIMar 1, 2023Subpotent Drug: low Anti-Factor IIa potency.
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDClass IIFeb 10, 2023Lack of sterility assurance: Recall of certain batches of 0.
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NClass IIFeb 10, 2023Lack of sterility assurance: Recall of certain batches of 0.
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. BethleheClass IINov 25, 2022Lack of sterility assurance: Bags have the potential to leak
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free acceClass IISep 15, 2022The extension set has a high probability of failure which c
Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended Class IISep 15, 2022The extension set has a high probability of failure which co
CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intClass IISep 15, 2022The extension set has a high probability of potential failur
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arteriClass IISep 1, 2022Potential for leakage at the catheter hub.
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800Class IIFeb 25, 2022Lack of sterility assurance: leaking bags
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made sClass IIFeb 7, 2022Units not properly inspected prior to release to the market,
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiratioClass IIJan 31, 2022This lot may have an elevated risk of leakage from the Air-I
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, ArticlClass IIJan 28, 2022Firm learned of the potential for cracks to form in the cond
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, ArticlClass IIJan 28, 2022Firm learned of the potential for cracks to form in the cond
OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infuClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump fClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT PClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System aClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infuClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the OutlookClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusionClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Class IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or HorClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System Class IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Class IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety InClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or HorClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT PumpClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump forClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion Class IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXTClass IIAug 10, 2021Leakage of the pump set within the cassette portion of the p
Infusomat Space Volumetric Pump Administration Set, Product Code 490100Class IIJun 25, 2021There is a potential for the Anti-free flow clip of the admi
Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: ThClass IIMar 15, 2021BBMI has identified through complaints the potential for the

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