Z-0211-2022Class II

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

Name: Z-0211-2022 QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Creator: Z-Medica, LLC
Published: 2021-09-22
License: https://open.fda.gov/license/

Z-Medica, LLC / initiated 2021-09-22 / Terminated / root cause: packaging

FDA source

Z-Medica, LLC began a recall of QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200 on 2021-09-22. FDA classified it as Class II and gives the reason as "Lack of Packaging seal integrity may result in a sterile barrier breach". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0211-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-22
Posted: 2021-11-05
Terminated: 2024-06-11
Recalling firm: Z-Medica, LLC
Product: QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Product code: FRO Dressing, Wound, Drug
Reason for recall: Lack of Packaging seal integrity may result in a sterile barrier breach.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Z-Medica notifed the customer via email on Wednesday 9/22/2021 and requested to place the products on hold. A formal notification letter was sent to the customer on 9/23/2021. Letter states reason for recall, health risk and action to take: We are requesting that you return all units of lot 12645 to Z-Medica, LLC ( 4 Fairfield Boulevard, Wallingford, CT 06492, ATTN: Recall - Regulatory Affairs). Please and return the attached Acknowledgement Form via email to [email protected]. If you have distributed any units of this lot number, please contact your customers and arrange for return of these units from lot 12645. Should you have any questions about this information please contact me at (203) 774-5686 or by email at [email protected]. issued Urgent Medical Device Recall letter
Quantity in commerce: 2400 units
Distribution: US Nationwide distribution in the state of NC.
Product codes and lots: Lot# 12645 UDI I Primary DI Number: 00841495102004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0211-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0211-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-17	2021-11-05

Product code FRO

K072474UnclassifiedQuikclot ExZ-Medica Corporation / cleared 2007-10-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)