DeRoyal CATARACT PACK CSM, REF 89-6863
DeRoyal Industries
Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
Stradis Medical, LLC
Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
Stradis Medical, LLC
Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
DeRoyal KIT HEART B PACK, REF 89-9042.07
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal SHOULDER PACK, REF 89-9449.13
DeRoyal Industries
Class I - Dangerous
XXX
HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
Stradis Medical, LLC
Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15
DeRoyal Industries
Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
DeRoyal KIT EXTREMITY PACK, REF 89-8869.09
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal RETINAL PACK, REF 89-7336.07
DeRoyal Industries
Class I - Dangerous
XXX
STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,
Stradis Medical, LLC
Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Becton Dickinson &
Class I - Dangerous
Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09
DeRoyal Industries
Class I - Dangerous
XXX
HENRY SCHEIN, Basin Set, Item No.570-1803
Stradis Medical, LLC
Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09
DeRoyal Industries
Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
Stradis Medical, LLC
Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03
DeRoyal Industries
Class I - Dangerous
XXX
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
ARROW INTERNATIONAL
Class I - Dangerous
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.