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U.S. Department of Health and Human Services

Class 2 Device Recall QuikClot TraumaPad

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  Class 2 Device Recall QuikClot TraumaPad see related information
Date Initiated by Firm May 17, 2017
Create Date June 19, 2017
Recall Status1 Terminated 3 on June 15, 2018
Recall Number Z-2612-2017
Recall Event ID 77316
510(K)Number K123387  
Product Classification Dressing, wound, drug - Product Code FRO
Product QuikClot TraumaPad, , sterile, soft, white, X-ray detectable
hemostatic dressing
Part Number 460
Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA
For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
Code Information Lot # 7313
Recalling Firm/
Manufacturer		 Z-Medica, LLC
4 Fairfield Blvd
Wallingford CT 06492-1857
For Additional Information Contact Joseph Azary
203-774-5686
Manufacturer Reason
for Recall		 Packaging breach may compromise sterility
FDA Determined
Cause 2		 Packaging process control
Action Z- Medica issued recall letters dated May 15, 2017, on May 17 2017, advising users of the problem and requesting customers to check their inventory and return product for replacement. Distributors requested to sub recall. Customers with questions were instructed to contact (203) 774-5686.
Quantity in Commerce 2910 pieces
Distribution Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRO and Original Applicant = Z-MEDICA, LLC
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