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U.S. Department of Health and Human Services

Class 2 Device Recall QStop

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 Class 2 Device Recall QStopsee related information
Date Initiated by FirmMay 16, 2025
Date PostedAugust 15, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2330-2025
Recall Event ID 97128
Product Classification Retention device, suture - Product Code KGS
ProductBrand 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 Lot Code: 00860011629405 (6-pack) Unit of use: 10860011629402
Recalling Firm/
Manufacturer		 Drs Vascular, Inc
1914 Otoole Way
San Jose CA 95131-2237
For Additional Information ContactRaj Subramaniam, PhD
+1-510-3312191
Manufacturer Reason
for Recall		XXX
FDA Determined
Cause 2		Device Design
ActionOn 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
Quantity in Commerce264
DistributionU.S. Nationwide distribution in the states of AR, CA, and NY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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