FDA Device recall Z-1407-2022
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle
- FDA Device
- Class II
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle by Roi Cps, citing some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1407-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-03 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | MO |
Product
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Reason
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Identifiers
| code_info | (1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249. |
|---|
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-1407-2022%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.