Recall Z-2337-2018 ยท MGB Device, Hemostasis, Vascular
Terumo Medical Corp
Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
| Date | Apr 9, 2018 |
| Status | Terminated |
| Reason | Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | On April 9, 2018, the firm sent Urgent Voluntary Medical Device Recall letters and Inventory Confirmation Forms to customers via FedEx. The letter described the product issue. Customers were asked to: 1. Review your Angio-Seal Evolution inventory immediately to identify and isolate affected inventory in order to prevent future use. 2. Your Terumo Territory Manager will visit your facility to confirm product inventory and assist you in completing the enclosed Recall Acknowledgement/ Inventory Confirmation Form. This required documentation, along with the enclosed Fed-Ex product shipment lab |
| Quantity | 240 |
| Distribution | Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.