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U.S. Department of Health and Human Services

Class 2 Device Recall Amerigel Wound Dressing 1 oz. tube

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  Class 2 Device Recall Amerigel Wound Dressing 1 oz. tube see related information
Date Initiated by Firm March 21, 2014
Date Posted July 04, 2014
Recall Status1 Terminated 3 on September 12, 2016
Recall Number Z-1992-2014
Recall Event ID 68488
510(K)Number K971918  
Product Classification Dressing, wound and burn, hydrogel w/drug and/or biologic - Product Code MGQ
Product Amerigel Wound Dressing 1 oz. tube
Code Information Lot #3WD02, Lot #3WD03, Lot #3WD04 and Lot #3WD05.
Recalling Firm/
Manufacturer		 Kova Laboratories, Inc.
1711 Banks Rd
Margate FL 33063-7744
For Additional Information Contact Kiki Sakai
954-978-8730
Manufacturer Reason
for Recall		 Product may not have been manufactured pursuant to a validated process protocol and CGMP.
FDA Determined
Cause 2		 Process control
Action Kova Laboratories contacted customers with an URGENT: Medical Device Recall message by phone and e-mail 3/21/2014 and 4/21/2014, of the affected products to be returned.
Quantity in Commerce 122,396 / 1oz. tubes
Distribution Distributed in the states of FL and NJ.
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 = MGQ and Original Applicant = AMERX HEALTH CARE CORP.
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