Device product
¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit
Z-0306-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 258 kits
- Official record key
device-enforcement:Z-0306-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10194717113485, Lot Numbers: 92643, exp 5/24/2024; 93393, exp 8/18/2024; 93669, exp 9/26/2024
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.