Recall Z-2330-2025 ยท KGS Retention Device, Suture
Drs Vascular, Inc
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No
| Date | Aug 15, 2025 (initiated May 16, 2025) |
| Status | Open, Classified |
| Reason | XXX |
| Root cause | Device Design |
| Action | On 05/29/2025, the firm sent via FedEx next day an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that they are conducting a voluntary recall of the Q-Stop Suture Retention Device Model QS due to some devices are prone to premature cutting of the suture. Customers are instructed to return all Q-Strop Suture Retention Device. Any used devices should be sent back in a sealed container. For questions contact firm at 510-345-7233 or mtaimisto@drsvascular.com |
| Quantity | 264 |
| Distribution | U.S. Nationwide distribution in the states of AR, CA, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.