QuikClot Combat Gauze-For Temporary External Use To Control… recallZ-0211-2022 · Z-Medica, LLC · initiated Sep 22, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Z-Medica, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Lack of Packaging seal integrity may result in a sterile barrier breach.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-0211-2022
- Status
- Terminated
- Initiated by the company
- Sep 22, 2021
- Recalling firm
- Z-Medica, LLC
- Quantity
- 2400 units
- Product code
- FRO
- FDA submissions
- K072474
- Distribution
- US Nationwide distribution in the state of NC.
Product description
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Code information (models, lots, serial numbers)
Lot# 12645 UDI I Primary DI Number: 00841495102004
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- QuikClot 0200Z-Medica, LLC · Dressing, Wound, Drug1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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