Recall Z-1295-2022 ยท OEZ Cardiovascular Procedure Kit
ROi CPS LLC
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
| Date | Jun 28, 2022 (initiated May 20, 2022) |
| Status | Terminated |
| Reason | A nonsterile component was packaged in a sterile convenience kit. |
| Root cause | Process change control |
| Action | The recalling firm called the consignee on 5/20/2022 to discuss the recall, including quarantine of affected product, customer fulfilment/available inventory, end user facility notification, recall timelines, and establishing a plan for relabeling by the recalling firm personnel at the distribution center. The recalling firm issued an email to the consignee on 5/20/2022 with an attached recall notice that was previously discussed with the consignee. The email requested the consignee to quarantine the kits and immediately notify the end user facilities who have been shipped the affected kits. |
| Quantity | 180 kits |
| Distribution | US Nationwide distribution in the state of FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.