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
FDA Recall Z-2330-2025 · Posted 2025-08-15
Recalling FirmDrs Vascular, Inc
Recall StatusOpen, Classified
Product CodeKGS
Date Initiated2025-05-16
Product Quantity264
Reason for Recall
XXX
Firm 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 [email protected]
Root Cause
Device Design
Distribution Pattern
U.S. Nationwide distribution in the states of AR, CA, and NY.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.