Device product
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.
Z-1004-2022
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 89875
- Status
- Terminated
- Classification
- Class II
- Quantity
- 290 convenience kits
- Official record key
device-enforcement:Z-1004-2022
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: (1) Item #830014015 - Lot number 87229O, exp. 5/31/2022 (2) Item #830014016 - Lot numbers 87952P, exp. 5/31/2022; 88219P, exp 6/30/2022; 89163, exp. 6/30/2022; 89430, exp. 5/31/2022; 89926, exp. 6/30/2022; 90372, exp, 6/30/2022; 91054, exp. 12/31/2022; and 91443, exp. 5/31/2023.
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.