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U.S. Department of Health and Human Services

Class 2 Device Recall ZMedica

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 Class 2 Device Recall ZMedicasee related information
Date Initiated by FirmSeptember 22, 2021
Create DateNovember 05, 2021
Recall Status1 Terminated 3 on June 11, 2024
Recall NumberZ-0211-2022
Recall Event ID 88818
510(K)NumberK072474 
Product Classification Dressing, wound, drug - Product Code FRO
ProductQuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Code Information Lot# 12645 UDI I Primary DI Number: 00841495102004
FEI Number 3004138549
Recalling Firm/
Manufacturer		 Z-Medica, LLC
4 Fairfield Blvd
Wallingford CT 06492-1857
For Additional Information ContactSAME
203-294-0000 Ext. 230
Manufacturer Reason
for Recall		Lack of Packaging seal integrity may result in a sterile barrier breach.
FDA Determined
Cause 2		Under Investigation by firm
ActionZ-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 in Commerce2400 units
Distribution US Nationwide distribution in the state of NC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRO
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