Z-1004-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2022
- Initiation Date
- March 18, 2022
- Termination Date
- August 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 290 convenience kits
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the state of Missouri.
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.