FDA recall Z-2330-2025

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 for recall

XXX

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-05-16

Report date

2025-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2330-2025