Device product
regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit
Z-0293-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 kits
- Official record key
device-enforcement:Z-0293-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10194717079958, Lot Numbers: 92037, exp 1/31/2023; 91205, exp 6/30/2023
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.