Z-1005-2022 Class II Terminated
FDA device recall Z-1005-2022 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: 1,501 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
- 1,501 convenience kits
Product Description
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery 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 Number: 830015013 - Lot numbers 87230M, exp. 5/31/2022; 87954M, exp. 5/31/2022; 88285M, exp. 5/31/2022; 88999M, exp. 6/30/2022; 89494, exp. 5/31/2022; 89985, exp. 6/30/2022; 90866, exp. 6/30/2022; and 91603, exp. 5/31/2023; and (2) Item 830084003 - Lot numbers 86155C, exp. 3/31/2022; 84799C, exp. 3/31/2022; 86735C. exp. 3/31/2022, 87269C, exp. 7/31/2022; 87871C, exp. 7/31/2022; 88564C, exp. 1/31/2023; 89260, exp. 2/28/2023; 89820, exp. 2/28/2023; 90253, exp. 1/31/2023; 90594, exp. 12/31/2022; and 91335, exp. 12/31/2022.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1005-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026