FDA Device recall Z-1004-2022
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mot…
- FDA Device
- Class II
- terminated
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mot… by Roi Cps, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1004-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-18 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | US |
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.
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.
Identifiers
| code_info | (1) Item #830014015 - Lot number 87229O, exp. 5/31/2022 (2) Item #830014016 - Lot numbers 87952P, exp. 5/31/2022; 8821…(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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1004-2022%22
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