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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 ZMedica see related information
Date Initiated by Firm September 22, 2021
Create Date November 05, 2021
Recall Status1 Open3, Classified
Recall Number Z-0211-2022
Recall Event ID 88818
510(K)Number K072474  
Product Classification Dressing, wound, drug - Product Code FRO
Product QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding
Model / Part# 200
Code Information Lot# 12645 UDI I Primary DI Number: 00841495102004
Recalling Firm/
Manufacturer		 Z-Medica, LLC
4 Fairfield Blvd
Wallingford CT 06492-1857
For Additional Information Contact SAME
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
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 in Commerce 2400 units
Distribution US Nationwide distribution in the state of NC.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRO and Original Applicant = Z-MEDICA CORPORATION
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