Z-0211-2022 Class II Terminated

Recalled by Z-Medica, LLC — Wallingford, CT

Recall Details

Product Type
Devices
Report Date
November 17, 2021
Initiation Date
September 22, 2021
Termination Date
June 11, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2400 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide distribution in the state of NC.

Code Information

Lot# 12645 UDI I Primary DI Number: 00841495102004