Device product
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Z-1295-2022
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 90302
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 kits
- Official record key
device-enforcement:Z-1295-2022
Official wording
Reason: A nonsterile component was packaged in a sterile convenience kit.
Code information: Lot #91423, Exp. 02/08/2024, UDI (01)10194717101949(17)240208(10)91423.
Distribution pattern: US Nationwide distribution in the state of FL.
Derived failure modes
-
Unknown
A nonsterile component was packaged in a sterile convenience kit.