Recall Z-0949-2022 ยท OEZ Cardiovascular Procedure Kit
Terumo Cardiovascular Systems Corp
Cardiovascular Procedure Kit catalog # 76645 & 73806
| Date | Feb 3, 2022 |
| Status | Terminated |
| Reason | Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping. |
| Root cause | Under Investigation by firm |
| Action | A customer notification letter was issued on 02/23/2022 by 2-day FedEx mailing advising customers to remove the affected product from use and return to Terumo CVS using the instructions provided. |
| Quantity | 64 |
| Distribution | US Nationwide distribution in the states of CA and IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.