FDA Medical Device Recalls (openFDA)
Drs Vascular, Inc: 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
- Recall number
- Z-2330-2025
- Recalling firm
- Drs Vascular, Inc
- 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
- Status
- Open, Classified
- Initiated
- 2025-05-16
- Posted
- 2025-08-15
- Terminated
- not on file
- Reason
- XXX
- Root cause
- Device Design
- Action
- 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
- Quantity
- 264
- Distribution
- U.S. Nationwide distribution in the states of AR, CA, and NY.
- Lot, serial or model codes
- Lot Code: 00860011629405 (6-pack) Unit of use: 10860011629402
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KGS
- Firm FEI
- 3030564133
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28