DeRoyal SPINE PACK, REF 89-8361.09
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
DeRoyal UNIVERSAL PACK, REF 89-9558.03
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02
DeRoyal Industries
Class I - Dangerous
XXX
HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,
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.
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), 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.
DeRoyal CATARACT PACK, REF 89-9241.03
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02
DeRoyal Industries
Class I - Dangerous
XXX
Class I - Dangerous
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.
DeRoyal BIOPSY PACKPACK, REF 89-9756.05
DeRoyal Industries
Class I - Dangerous
XXX
STRADIS HEALTHCARE, Vein, Item No.682-577,
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 LUMBAR DISC PACK, REF 89-10605.02
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal PORT PACK PGYBK, REF 89-8748.05
DeRoyal Industries
Class I - Dangerous
XXX
GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07
DeRoyal Industries
Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), 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.
DeRoyal LUMBAR FUSION PACK, REF 89-10211.05
DeRoyal Industries
Class I - Dangerous
XXX
STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,
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, VEIN TRAY, Item No.570-2738,
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.
STRADIS HEALTHCARE, Angio Pack, Item No.686-199,
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.
STRADIS HEALTHCARE, Lipo, Item No.681-254,
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.