Recall Z-0966-2019 ยท OEZ Cardiovascular Procedure Kit
Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
| Date | Dec 20, 2018 |
| Status | Terminated |
| Reason | Presence of natural rubber latex is not declared in the label |
| Root cause | Component design/selection |
| Action | Terumo issued Urgent Medical Device Recall dated 12/20/18 stating reason for recall, health risk and an appropriate course of action for the return of affected product to Terumo. Questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET. |
| Quantity | 12 packs |
| Distribution | TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.