Device product
¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
Z-0303-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 108 kits
- Official record key
device-enforcement:Z-0303-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10194717114895, Lot Numbers: 92534, exp 11/13/2022; 93366, exp 2/28/2023
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.