Recall Z-0211-2022— Z-Medica, LLC

Name: FDA recall Z-0211-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-22

Class II · Terminated

Class II FDA medical device recall by Z-Medica, LLC, initiated 2021-09-22, terminated 2024-06-11. It names one FDA 510(k) clearance: K072474. Product: QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200. Reason: Lack of Packaging seal integrity may result in a sterile barrier breach..

Recalling firm: Z-Medica, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-09-22
Terminated: 2024-06-11
Firm location: Wallingford, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K072474 — QUIKCLOT EXZ-Medica Corporation·cleared 2007-10-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.