Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Descript
Summary
The FDA issued a Class II for Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: Q by Drs Vascular, Inc. Reason: XXX.
Details
Source
Device Recall
External ID
Z-2330-2025
Action Date
2025-08-27
Status
Ongoing
Category
device
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
Lot/Code Info: Lot Code: 00860011629405 (6-pack) Unit of use: 10860011629402
Quantity Affected: 264
Reason for Recall
XXX
Distribution
U.S. Nationwide distribution in the states of AR, CA, and NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-16
Company
San Jose, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 135 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Drs Vascular, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Drs Vascular, Inc have FDA actions?
This is the only FDA action we have on record for Drs Vascular, Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2330-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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