Z-0620-2024 Class I Terminated
FDA device recall Z-0620-2024 was initiated by ROi CPS LLC on December 18, 2023 and is designated Class I. Reason for recall: Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist. The recall status is terminated (terminated October 3, 2024). Affected quantity: 345 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- December 18, 2023
- Termination Date
- October 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 345 units
Product Description
regard Operative LAP, Item Number 800943001; surgical convenience kit
Reason for Recall
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
Distribution Pattern
US distribution to Louisiana
Code Information
UDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845