Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
GE Medical Systems
There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Baxter Healthcare
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Baxter Healthcare
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
Stradis Medical, LLC
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 MYELOGRAM PACK, REF 89-9304.05
DeRoyal Industries
XXX
DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11
DeRoyal Industries
XXX
STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
Stradis Medical, LLC
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 VIT RD PACK 86ST, REF 89-7308.09
DeRoyal Industries
XXX
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
ARROW INTERNATIONAL
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
Stradis Medical, LLC
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 AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
ARROW INTERNATIONAL
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
ARROW INTERNATIONAL
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
DeRoyal FOOT PACK, REF 89-9252.08
DeRoyal Industries
XXX
DeRoyal PAIN TRAY, REF 89-10464.03
DeRoyal Industries
XXX
HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
Stradis Medical, LLC
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 SHOULDER KIT, REF 89-9497.08
DeRoyal Industries
XXX
DeRoyal CANNULTED HIP PACK, REF 89-6977.10
DeRoyal Industries
XXX
DeRoyal TRANS CANAL PACK, REF 89-7157.12
DeRoyal Industries
XXX
DeRoyal FACIAL PACK PGYBK, REF 89-10007.03
DeRoyal Industries
XXX