FDA Device recall Z-1295-2022
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile
- FDA Device
- Class II
- terminated
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile by Roi Cps, citing A nonsterile component was packaged in a sterile convenience kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1295-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-20 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | US |
Product
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Reason
A nonsterile component was packaged in a sterile convenience kit.
Identifiers
| code_info | Lot #91423, Exp. 02/08/2024, UDI (01)10194717101949(17)240208(10)91423. |
|---|
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-1295-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.