Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Descr... — FDA record Z-2330-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 16, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Reason
XXX
Classification
Class II
Recalling firm
Drs Vascular, Inc
Quantity
264
Agency-reported status
Ongoing
Source record identifier
Z-2330-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot Code: 00860011629405 (6-pack) Unit of use: 10860011629402

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

U.S. Nationwide distribution in the states of AR, CA, and NY.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Aug 27, 2025
Recall initiation date
May 16, 2025
Center classification date
Aug 15, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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