MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Atrium Medical
Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Class I - Dangerous
Drug flow rates exceeding programmed flow rates.
GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip used between the end bell covers and patient bore of certain GE MR Products may extend past the surface of the covers. The foam itself is not hazardous. However, any fluid or body substance absorbed
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
Radiometer America
Class I - Dangerous
RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane.
Class I - Dangerous
Drug flow rates exceeding programmed flow rates.
Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Atrium Medical
Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Class I - Dangerous
No antibacterial bandages were packed in boxes labeled as antibacterial.
Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size.
Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
Class I - Dangerous
Drug flow rates exceeding programmed flow rates.
Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Class I - Dangerous
Drug flow rates exceeding programmed flow rates.
Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.
Class I - Dangerous
Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.