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Recall Observatory FDA recall evidence

Device 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

Z-2330-2025

May 16, 2025

Class II

Product summary

Firm
Drs Vascular, Inc
Event
Event 97128
Status
Ongoing
Classification
Class II
Quantity
264
Official record key
device-enforcement:Z-2330-2025

Official wording

Reason: XXX

Code information: Lot Code: 00860011629405 (6-pack) Unit of use: 10860011629402

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    XXX