Device product
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
Z-1006-2022
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 89875
- Status
- Terminated
- Classification
- Class II
- Quantity
- 950 convenience kits
- Official record key
device-enforcement:Z-1006-2022
Official wording
Reason: A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Code information: Lot numbers 89889, exp. 5/12/2022; 90446, exp. 5/12/2022; and 90641, exp. 5/12/2022.
Distribution pattern: US Nationwide distribution in the state of Missouri.
Derived failure modes
-
Unknown
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.