Brand Name: Q-Stop recallZ-2330-2025 · Drs Vascular, Inc · initiated May 16, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Drs Vascular, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
XXX
FDA root cause category: Device Design
What the company is doing
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]
Recall details
- Recall number
- Z-2330-2025
- Status
- Open, Classified
- Initiated by the company
- May 16, 2025
- Posted by the FDA
- Aug 15, 2025
- Recalling firm
- Drs Vascular, Inc
- Quantity
- 264
- Product code
- KGS
- Distribution
- U.S. Nationwide distribution in the states of AR, CA, and NY.
Product description
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
Code information (models, lots, serial numbers)
Lot Code: 00860011629405 (6-pack) Unit of use: 10860011629402
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Q-Stop QSDRS Vascular, Inc. · Retention Device, Suture1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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