Device product
Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
Z-1408-2022
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 90492
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 kits
- Official record key
device-enforcement:Z-1408-2022
Official wording
Reason: Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Code information: Lot #92605, exp. 8/31/2023, Item #830014016, UDI #10194717110156.
Distribution pattern: Distribution was made to MO. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.