FDA Medical devices recall ·
Q-Stop Product Name: Suture Retention Device Model recall
- Recall number
- Z-2330-2025
- Date
- (initiated May 16, 2025)
- Company / brand
- Drs Vascular, Inc
1914 Otoole Way, San Jose, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 264
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
XXX
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: 00860011629405 (6-pack) Unit of use: 10860011629402
Distribution
U.S. Nationwide distribution in the states of AR, CA, and NY.
States: Arkansas California New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2330-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.