FDA Device recall Z-1051-2022
Regard brand CABG Pack A and B - Spartanburg
- FDA Device
- Class II
- terminated
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of Regard brand CABG Pack A and B - Spartanburg by Roi Cps, citing kits were packed into shipping boxes incorrectly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1051-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-21 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | NC |
Product
Regard brand CABG Pack A and B - Spartanburg
Reason
Kits were packed into shipping boxes incorrectly.
Identifiers
| code_info | Item Number: 800208017, Lot 91156 UDI: (01)10194717112495(17)230101(10)91156 |
|---|
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-1051-2022%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.