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Medline Industries Inc. FDA Recalls
19 recalls on file across devices, drugs, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Medline CHEST TUBE REORDER NO: DYNJ36762AClass IIJul 21, 2022Due to a non-sterile component (tape) being place within the |
| Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC Class IINov 8, 2021Defective Container: Customer complaints for leaking bottles |
| Venous Access Pack-LF Convenience KitClass IIOct 27, 2021NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration |
| EVLP Convenience Pack/KitClass IIOct 27, 2021NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration |
| Bedside PICC CDS Convenience KitClass IIOct 27, 2021NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration |
| Major Vascular CDS Convenience KitClass IIOct 27, 2021NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration |
| Neuro Convenience KitClass IIOct 27, 2021NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration |
| NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve ManifoClass IIAug 6, 2021Potential for sterile barrier breach. Microscopic pinholes |
| NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with RotatClass IIAug 6, 2021Potential for sterile barrier breach. Microscopic pinholes |
| Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. datClass IIJul 1, 2021The kits may contain an expired component. |
| Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (expClass IIJul 1, 2021The kits may contain an expired component. |
| Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation BagClass IIJul 1, 2021The kits may contain an expired component. |
| Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL IrrClass IIJul 1, 2021The kits may contain an expired component. |
| Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures softClass IIMay 25, 2021Potential for mold contamination (Aspergillus vadensis) |
| READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use OClass IIIMay 14, 2021Superpotent Drug: Product is above specification for active |
| Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to rClass IIApr 30, 2021The devices may not meet the minimum required sterility assu |
| Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test carClass IIMar 15, 2021Possible false negative or false positive results due to the |
| RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue HemoglobClass IIJan 25, 2021Product was compromised during shipment. |
| S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the Class IIIJan 15, 2021Medline Industries, Inc. is removing specific lots of STAT-S |