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

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