Device product
Regard brand CABG Pack A and B - Spartanburg
Z-1051-2022
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 89951
- Status
- Terminated
- Classification
- Class II
- Quantity
- 85 kits
- Official record key
device-enforcement:Z-1051-2022
Official wording
Reason: Kits were packed into shipping boxes incorrectly.
Code information: Item Number: 800208017, Lot 91156 UDI: (01)10194717112495(17)230101(10)91156
Distribution pattern: Recall impacted one domestic consignee in NC
Derived failure modes
-
Unknown
Kits were packed into shipping boxes incorrectly.