Z-0300-2023 Class II Terminated
FDA device recall Z-0300-2023 was initiated by ROi CPS LLC on Oct 20, 2022 and is designated Class II. Reason for recall: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. The recall status is terminated (terminated Apr 1, 2026). Affected quantity: 32 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 30, 2022
- Initiation Date
- Oct 20, 2022
- Termination Date
- Apr 1, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 kits
Product Description
regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
Reason for Recall
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Distribution Pattern
LA, MO, NC, FL
Code Information
UDI/DI 10194717101611, Lot Numbers: 92674, exp 9/30/2023; 93459, exp 9/30/2023,