Device product
Regard Dressing Change Tray
Z-1542-2021
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 87658
- Status
- Terminated
- Classification
- Class II
- Quantity
- 272 trays
- Official record key
device-enforcement:Z-1542-2021
Official wording
Reason: ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
Code information: Lot Numbers: 86983C, 87081C and 86356C.
Distribution pattern: US Nationwide distribution in the state of Louisiana.
Derived failure modes
-
Unknown
ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.