Recall Z-1611-2023 ยท MGB Device, Hemostasis, Vascular
TELEFLEX LLC
Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.
| Date | May 18, 2023 (initiated Apr 12, 2023) |
| Status | Open, Classified |
| Reason | The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product. |
| Root cause | Under Investigation by firm |
| Action | Teleflex issued an URGENT - MEDICAL DEVICE RECALL notice to its consignees on 04/12/2023 via FedEx 2nd day. The notice explained the issue and the hazard and requested the following actions be taken: Medical Facilities - immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. If impacted product is on hand, mark the applicable checkbox on the Acknowledgement Form and fax it to 1-855-419-8507, including Attn: Customer Service or using the email address recalls@te |
| Quantity | 1140 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.