Device product
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Z-1407-2022
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 90492
- Status
- Terminated
- Classification
- Class II
- Quantity
- 86 kits
- Official record key
device-enforcement:Z-1407-2022
Official wording
Reason: Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Code information: (1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249.
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.