Device product
Regard, T AND A - Rogers, sterilized convenience kits
Z-0469-2022
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 89149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 195 kits
- Official record key
device-enforcement:Z-0469-2022
Official wording
Reason: Kits lacks rubber latex warning label.
Code information: 1) Item Number 8800313004, Lot Number 89090D (UDI 10194717110804); Expiration 07/15/2023 2) Item Number 8800313005, Lot Number 89378 (UDI 10194717112730); Expiration 08/05/2023
Distribution pattern: US Nationwide distribution in the state of MO.
Derived failure modes
-
Unknown
Kits lacks rubber latex warning label.