Z-2330-2025Class II

Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A...

Name: Z-2330-2025 Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A...
Creator: Drs Vascular, Inc
Published: 2025-05-16
License: https://open.fda.gov/license/

Drs Vascular, Inc / initiated 2025-05-16 / Open, Classified / root cause: design

FDA source

Drs Vascular, Inc began a recall of 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... on 2025-05-16. FDA classified it as Class II and gives the reason as "XXX". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2330-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-16
Posted: 2025-08-15
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
Product code: KGS Retention Device, Suture
Reason for recall: XXX
Root cause tag: design
FDA 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 [email protected]
Quantity in commerce: 264
Distribution: U.S. Nationwide distribution in the states of AR, CA, and NY.
Product codes and lots: Lot Code: 00860011629405 (6-pack) Unit of use: 10860011629402

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2330-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2330-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-15

Product code KGS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)