QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
FDA Recall Z-0211-2022 · Posted None
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Recalling FirmZ-Medica, LLC
Recall StatusTerminated
Product CodeFRO
Date Initiated2021-09-22
Date Terminated2024-06-11
Product Quantity2400 units
Reason for Recall
Lack of Packaging seal integrity may result in a sterile barrier breach.
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
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the state of NC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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