Device product
¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit
Z-0308-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 213 kits
- Official record key
device-enforcement:Z-0308-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10194717103301, Lot Numbers: 91005, exp 2/27/2023; 91543, exp 2/16/2024
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.