Z-1004-2022 Class II Terminated
FDA device recall Z-1004-2022 was initiated by ROi CPS LLC on Mar 18, 2022 and is designated Class II. 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. The recall status is terminated (terminated Aug 2, 2024). Affected quantity: 290 convenience kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2022
- Initiation Date
- Mar 18, 2022
- Termination Date
- Aug 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1004-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026