← Every firm
DeRoyal Industries Inc FDA Recalls
188 recalls on file across devices, 4 of them Class I and 175 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 |
|---|
| REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 SeriesClass IIAug 20, 2026Myocardial temperature probes contain an incorrect needle. S |
| DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)Class IIMay 18, 2026Sterile wound dressing, lacks sterility assurance |
| DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-CClass IIJan 31, 2025Due to the inner diameter of the suction tubing connector be |
| DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for flClass IIJan 15, 2025The tubing may not ensure that the yankauer stays intact, an |
| DeRoyal C-SECTION TRACEPACK, REF 89-9338-06Class IIOct 3, 2024DeRoyal is recalling certain lots of surgical procedure pack |
| DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06Class IIOct 3, 2024DeRoyal is recalling certain lots of surgical procedure pack |
| DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06Class IIOct 3, 2024DeRoyal is recalling certain lots of surgical procedure pack |
| DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06Class IIOct 3, 2024DeRoyal is recalling certain lots of surgical procedure pack |
| GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECARTClass IFeb 13, 2024DeRoyal manufactured and distributed Surgical Tracecarts tha |
| DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572Class IINov 22, 2023Kit were manufactured and distributed with Edwards Life Scie |
| DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kitClass IISep 18, 2023DeRoyal is recalling certain lots of surgical procedure pack |
| Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219Class IIMay 30, 2023The outer package seal could be open, or compromised which a |
| Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-Class IIMay 30, 2023The outer package seal could be open, or compromised which a |
| Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014Class IIMay 30, 2023The outer package seal could be open, or compromised which a |
| Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-1090Class IIMay 30, 2023The outer package seal could be open, or compromised which a |
| Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REClass IIMay 30, 2023The outer package seal could be open, or compromised which a |
| Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.Class IIApr 17, 2023The custom procedure packs contain light handle covers that |
| Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; anClass IIApr 17, 2023The custom procedure packs contain light handle covers that |
| DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000BClass IIFeb 9, 2023The reason for the voluntary recall is due to shrinkage of t |
| DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10Class IIDec 12, 2022DeRoyal is recalling certain lots of surgical procedure pack |
| DeRoyal Tonsillectomy Tray, REF 89-10698.01Class IINov 28, 2022DeRoyal is recalling certain lots of surgical procedure pack |
| DeRoyal NEURO PACK, REF 89-9253.07Class IINov 3, 2022XXX |
| DeRoyal PAIN TRAY, REF 89-10464.02Class IINov 3, 2022XXX |
| DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10Class IINov 3, 2022XXX |
| DeRoyal CANNULTED HIP PACK, REF 89-6977.10Class IINov 3, 2022XXX |
| DeRoyal TRANS CANAL PACK, REF 89-7157.12Class IINov 3, 2022XXX |
| GEO-MED BIOPSY TRAY, REF 89-8753.01Class IINov 3, 2022XXX |
| DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04Class IINov 3, 2022XXX |
| DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02Class IINov 3, 2022XXX |
| DeRoyal TOTAL KNEE PACK, REF 89-9300.08Class IINov 3, 2022XXX |
| DeRoyal MAJOR ORTHO PACK, REF 89-9250.07Class IINov 3, 2022XXX |
| DeRoyal SPINE PACK, REF 89-8361.09Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07Class IINov 3, 2022XXX |
| DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02Class IINov 3, 2022XXX |
| DeRoyal BASIC NEURO PACK, REF 89-7523.16Class IINov 3, 2022XXX |
| DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14Class IINov 3, 2022XXX |
| DeRoyal BREAST TRAY, REF 89-7033.07Class IINov 3, 2022XXX |
| DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05Class IINov 3, 2022XXX |
| DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01Class IINov 3, 2022XXX |
| DeRoyal UNIVERSAL PACK, REF 89-9558.03Class IINov 3, 2022XXX |
| DeRoyal PODIATRY PACK, REF 89-8359.10Class IINov 3, 2022XXX |
| DeRoyal PACEMAKER ICD PACK, REF 89-10216.06Class IINov 3, 2022XXX |
| DeRoyal SHOULDER PACK, REF 89-6830.13Class IINov 3, 2022XXX |
| DeRoyal CATARACT PACK, REF 89-9241.03Class IINov 3, 2022XXX |
| DeRoyal VIT RD PACK 86ST, REF 89-7308.09Class IINov 3, 2022XXX |
| DeRoyal HEART PACK, REF 89-8351.11Class IINov 3, 2022XXX |
| DeRoyal EYE PACK, REF 89-4051.09Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09Class IINov 3, 2022XXX |
| DeRoyal FACIAL PACK PGYBK, REF 89-10007.03Class IINov 3, 2022XXX |
| DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12Class IINov 3, 2022XXX |
| DeRoyal CATARACT PACK CSM, REF 89-6863Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal LAMINECTOMY PACK, REF 89-10209.02Class IINov 3, 2022XXX |
| DeRoyal NEURO PACK, REF 89-10682.02Class IINov 3, 2022XXX |
| DeRoyal KIT HEART B PACK, REF 89-9042.07Class IINov 3, 2022XXX |
| DeRoyal CATARACT PACK, REF 89-10086.05Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal BASIC EYE PACK, REF 89-9233.08Class IINov 3, 2022XXX |
| DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01Class IINov 3, 2022XXX |
| DeRoyal KIT EXTREMITY PACK, REF 89-8869.09Class IINov 3, 2022XXX |
| GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal NEURO PACK, REF 89-9253.09Class IINov 3, 2022XXX |
| DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03Class IINov 3, 2022XXX |
| DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03Class IINov 3, 2022XXX |
| DeRoyal MYELOGRAM PACK, REF 89-9304.05Class IINov 3, 2022XXX |
| DeRoyal CUSTOM NEURO PACK, REF 89-7353.17Class IINov 3, 2022XXX |
| DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11Class IINov 3, 2022XXX |
| DeRoyal KIT TOTAL HIP, REF 89-8861.07Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal PEDI ORTHO PACK, REF 89-5323.20Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal BIOPSY PACKPACK, REF 89-9756.05Class IINov 3, 2022XXX |
| DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11Class IINov 3, 2022XXX |
| DeRoyal BASIC PACK, REF 89-8633.07Class IINov 3, 2022XXX |
| GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02Class IINov 3, 2022XXX |
| DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02Class IINov 3, 2022XXX |
| DeRoyal BIOPSY PACK, REF 89-9739.05Class IINov 3, 2022XXX |
| DeRoyal HEART PACK, REF 89-8351.13Class IINov 3, 2022XXX |
| DeRoyal SPINAL FUSION PACK, REF 89-7515.12Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06Class IINov 3, 2022XXX |
| DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08Class IINov 3, 2022XXX |
| DeRoyal BASIC NEURO PACK, REF 89-7258.13Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal CATARACT PACK, REF 89-9241.04Class IINov 3, 2022XXX |
| DeRoyal CRANI PACK, REF 89-10202.03Class IINov 3, 2022XXX |
| DeRoyal ACDF PACK, REF 89-8779.03Class IINov 3, 2022XXX |
| DeRoyal RETINAL PACK, REF 89-7336.07Class IINov 3, 2022XXX |
| GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09Class IINov 3, 2022XXX |
| GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02Class IINov 3, 2022XXX |
| DeRoyal BASIC EYE PACK, REF 89-8337.09Class IINov 3, 2022XXX |
| DeRoyal SPINE PACK, REF 89-8361.08Class IINov 3, 2022XXX |
| DeRoyal SHOULDER KIT, REF 89-9497.08Class IINov 3, 2022XXX |
| DeRoyal SHOULDER PACK, REF 89-9449.13Class IINov 3, 2022XXX |
| DeRoyal BIOPSY PACK, REF 89-9614.07Class IINov 3, 2022XXX |
| DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal EYE TRAY, REF 89-4957.08Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal TOTAL HIP PACK, REF 89-9113.06Class IINov 3, 2022XXX |
| DeRoyal BASIC NEURO PACK, REF 89-7258.10Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03Class IINov 3, 2022XXX |
| DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02Class IINov 3, 2022XXX |
| GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal CRANI PACK, REF 89-10242.02Class IINov 3, 2022XXX |
| DeRoyal LAPINECTOMY PACK, REF 89-7198.11Class IINov 3, 2022XXX |
| DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal GU PACK, REF 89-10665.03Class IINov 3, 2022XXX |
| DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03Class IINov 3, 2022XXX |
| DeRoyal FOOT PACK, REF 89-9252.08Class IINov 3, 2022XXX |
| DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02Class IINov 3, 2022XXX |
| DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09Class IINov 3, 2022XXX |
| DeRoyal TLIF PACK, REF 89-8780.04Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal FOOT PACK, REF 89-9252.07Class IINov 3, 2022XXX |
| DeRoyal PAIN TRAY, REF 89-10464.03Class IINov 3, 2022XXX |
| GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01Class IINov 3, 2022XXX |
| DeRoyal EYE PACK, REF 89-8756.03Class IINov 3, 2022XXX |
| DeRoyal TOTAL HIP KIT, REF 89-9498.10Class IINov 3, 2022XXX |
| DeRoyal CUSTOM NEURO PACK, REF 89-8392.09Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal CATARACT PACK, REF 89-7135.10Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal SPINE PACK, REF 89-8361.10Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal GU ROBOTIC PACK, REF 89-7063.12Class IINov 3, 2022XXX |
| GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01Class IINov 3, 2022XXX |
| DeRoyal BASIC EYE PACK, REF 89-8337.08Class IINov 3, 2022XXX |
| GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal NEURO PACK, REF 89-10171.06Class IINov 3, 2022XXX |
| DeRoyal BIOPSY PACK, REF 89-9270.05Class IINov 3, 2022XXX |
| DeRoyal BIOPSY PACK, REF 89-9270.04Class IINov 3, 2022XXX |
| DeRoyal FOOT PACK, REF 89-9252.06Class IINov 3, 2022XXX |
| DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02Class IINov 3, 2022XXX |
| DeRoyal BIOPSY PACK, REF 89-9739.06Class IINov 3, 2022XXX |
| DeRoyal LAMI/CRANI PACK, REF 89-10787.01Class IINov 3, 2022XXX |
| DeRoyal HAND PACK, REF 89-10314.02Class IINov 3, 2022XXX |
| DeRoyal HEART PACK, REF 89-8351.12Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal TOTAL HIP PACK, REF 89-9113.07Class IINov 3, 2022XXX |
| DeRoyal PACEMAKER ICD PACK, REF 89-10902.01Class IINov 3, 2022XXX |
| DeRoyal SPINAL FUSION PACK, REF 89-7515.14Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal CRANI PACK, REF 89-10202.05Class IINov 3, 2022XXX |
| DeRoyal CATARACT PACK, REF 89-8650.10Class IINov 3, 2022XXX |
| DeRoyal LUMBAR DISC PACK, REF 89-10590.02Class IINov 3, 2022XXX |
| DeRoyal LAPINECTOMY PACK, REF 89-7198.10Class IINov 3, 2022XXX |
| DeRoyal CNRV SPINAL PACK, REF 89-10532.03Class IINov 3, 2022XXX |
| DeRoyal PORT PACK PGYBK, REF 89-8748.05Class IINov 3, 2022XXX |
| DeRoyal BASIC NEURO PACK, REF 89-7258.12Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal GU PACK, REF 89-10665.02Class IINov 3, 2022XXX |
| DeRoyal BASIC NEURO PACK, REF 89-7523.15Class IINov 3, 2022XXX |
| GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02Class IINov 3, 2022XXX |
| DeRoyal LUMBAR DISC PACK, REF 89-10605.02Class IINov 3, 2022XXX |
| DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13Class IINov 3, 2022XXX |
| DeRoyal CATARACT PACK, REF 89-10040.01Class IINov 3, 2022XXX |
| DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10Class IINov 3, 2022XXX |
| DeRoyal MYELOGRAM PACK, REF 89-9304.06Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal LUMBAR FUSION PACK, REF 89-10211.05Class IINov 3, 2022XXX |
| DeRoyal SPINAL FUSION PACK, REF 89-7515.13Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04Class IINov 3, 2022XXX |
| DeRoyal SHOULDER PACK, REF 89-9449.12Class IINov 3, 2022XXX |
| DeRoyal TOTAL HIP KIT, REF 89-9498.08Class IINov 3, 2022XXX |
| DeRoyal KIT HEART B PACK, REF 89-9042.08Class IINov 3, 2022XXX |
| GEO-MED CATARACT PACK, REF 89-5790.08Class IINov 3, 2022XXX |
| DeRoyal ENDOVENOUS PACK, REF 89-7762.05Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal CATARACT PACK, REF 89-8859.08Class IINov 3, 2022XXX |
| DeRoyal CRANI PACK, REF 89-10242.04Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01Class IINov 3, 2022XXX |
| DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02Class IINov 3, 2022XXX |
| DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05Class IINov 3, 2022XXX |
| DeRoyal PODIATRY PACK, REF 89-8359.13Class IINov 3, 2022XXX |
| DeRoyal HAND PACK, REF 89-10314.03Class IINov 3, 2022XXX |
| DeRoyal CARDIAC LINEN PACK, REF 89-10543.02Class IINov 3, 2022XXX |
| DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal NEURO PACK, REF 89-10171.05Class IINov 3, 2022XXX |
| DeRoyal TOTAL HIP PACK, REF 89-9301.07Class IINov 3, 2022XXX |
| GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal CUSTOM NEURO PACK, REF 89-8392.10Class IINov 3, 2022XXX |
| DeRoyal PACEMAKER ICD PACK, REF 89-10216.03Class IINov 3, 2022XXX |
| DeRoyal NEURO PACK, REF 89-10171.03Class IINov 3, 2022XXX |
| GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02Class IINov 3, 2022XXX |
| DeRoyal SHOULDER KIT, REF 89-9497.10Class IINov 3, 2022XXX |
| GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal EYE TRAY PGYBK, REF 89-7978.02Class IINov 3, 2022DeRoyal procedure packs that contain the affected 3M Health |
| DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear ConnectorsClass IIAug 12, 2022Procedure packs contained a recalled product. |
| DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, AnklClass IIJul 15, 2022The webbing strap was laced improperly through the teeth of |
| DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcoholClass IIMar 3, 2022A kit component, the PDI Prevantics Swab was recalled due to |
| DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preClass IIMar 3, 2022A kit component, the PDI Prevantics Swab was recalled due to |
| DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swabClass IIMar 3, 2022A kit component, the PDI Prevantics Swab was recalled due to |
| DeRoyal Angio Cath Removal Tray, REF 89-9936.02Class IMay 14, 2021DeRoyal manufactured certain lots of surgical procedure pack |
| DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06Class IMay 14, 2021DeRoyal manufactured certain lots of surgical procedure pack |
| DeRoyal Heart Cath Procedure Pack, REF 89-6556.08Class IMay 14, 2021DeRoyal manufactured certain lots of surgical procedure pack |
| Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical proceduClass IIJan 25, 2021Sternum saw blades within procedure packs are not sterile. T |
| Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packClass IIJan 25, 2021Sternum saw blades within procedure packs are not sterile. T |
| CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.Class IIJan 25, 2021Sternum saw blades within procedure packs are not sterile. T |