Device product
regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0045-2016
Product summary
- Event
- Event 71904
- Status
- Terminated
- Classification
- Class II
- Quantity
- 222 kits
- Official record key
device-enforcement:Z-0045-2016
Official wording
Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Code information: Lot numbers 16235, 19073, 19511, 20078, 20239, 20868, and 21849.
Distribution pattern: Distribution was made to LA, MS, and TX.
Derived failure modes
-
Unknown
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.