Drs Vascular, Inc recalls Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Softw…
Reason for recall
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Affected product
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Affected products & lots
- 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: No2 affected lots0086001162940510860011629402
What the firm 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 mtaimisto@drsvascular.com
DistributionShow detailsHide
U.S. Nationwide distribution in the states of AR, CA, and NY.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2330-2025
- FDA device classification · KGSOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4930The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Drs Vascular, IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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