FDAClass IINovember 17, 2021

QuikClot Combat Gauze-For Temporary External Use To recall: Sterility Concern

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

Why was QuikClot Combat Gauze-For Temporary External Use To recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 12645 UDI I Primary DI Number: 00841495102004

Product
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Recalling firm
Z-Medica, LLC
Quantity
2400 units
Distribution
US Nationwide distribution in the state of NC.
Recall date
November 17, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls