Medical device recalls Moderate risk

Z-Medica, LLC recalls QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200

Recall date
September 22, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0211-2022
FDA classification
Class II
Brand / firm
Z-Medica, LLC
Sold / distributed
US Nationwide distribution in the state of NC.

Why it was recalled

Lack of Packaging seal integrity may result in a sterile barrier breach.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200

Get recall alerts

Free email alert whenever Z-Medica, LLC has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Z-Medica, LLC