Z-Medica, LLC: Medical Device Recall in 2021 - (Recall #: Z-0211-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 22, 2021

Date Posted: November 17, 2021

Recall Number: Z-0211-2022

Event ID: 88818

Reason for Recall:

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

Status: Terminated

Product Quantity: 2400 units

Code Information:

Lot# 12645 UDI I Primary DI Number: 00841495102004

Distribution Pattern:

US Nationwide distribution in the state of NC.

Voluntary or Mandated:

Voluntary: Firm initiated