FDA Medical Device Recalls (openFDA)
Z-Medica, LLC: QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
- Recall number
- Z-0211-2022
- Recalling firm
- Z-Medica, LLC
- Product
- QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
- Status
- Terminated
- Initiated
- 2021-09-22
- Posted
- not on file
- Terminated
- 2024-06-11
- Reason
- Lack of Packaging seal integrity may result in a sterile barrier breach.
- 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 joseph.azary@teleflex.com. 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 joseph.azary@teleflex.com. issued Urgent Medical Device Recall letter
- Quantity
- 2400 units
- Distribution
- US Nationwide distribution in the state of NC.
- Lot, serial or model codes
- Lot# 12645 UDI I Primary DI Number: 00841495102004
- 510(k) numbers
- ["K072474"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3004138549
- Firm city
- Wallingford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28