Recall Z-1051-2022 ยท OEZ Cardiovascular Procedure Kit
ROi CPS LLC
Regard brand CABG Pack A and B - Spartanburg
| Date | Mar 21, 2022 |
| Status | Terminated |
| Reason | Kits were packed into shipping boxes incorrectly. |
| Root cause | Under Investigation by firm |
| Action | An email notification of the recall was sent to the single impacted consignee (a distributor) on 03/29/2022. The consignee was instructed to complete the following: 1) Check: Please review inventory and determine if affected product is inventory. 2) Quarantine: Kits containing a special inspection label are approved to be used. Only quarantine and report kits that do not have this special label. If unlabeled kits are identified, immediately quarantine and do not further distribute. 3) Reply: Complete reply form indicating the number of kits in quarantine. Send the reply to lacy.stewart@roiscs |
| Quantity | 85 kits |
| Distribution | Recall impacted one domestic consignee in NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.