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U.S. Department of Health and Human Services

Class 2 Device Recall Amerigel Saturated Gauze Dressing

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  Class 2 Device Recall Amerigel Saturated Gauze Dressing see related information
Date Initiated by Firm September 26, 2014
Date Posted December 04, 2014
Recall Status1 Terminated 3 on October 03, 2016
Recall Number Z-0500-2015
Recall Event ID 69394
510(K)Number K971918  
Product Classification Dressing, wound and burn, hydrogel w/drug and/or biologic - Product Code MGQ
Product Amerigel Saturated Gauze Dressing

Wound management
Code Information Model # A5002, Lot #s: 05368, 05345, 09282, 10295, 12201, 12303, 12322, 12328, 13100, 13115, 13180
Recalling Firm/
Amerx Health Care Corp.
1300 S. Highland Avenue
Clearwater FL 33756
For Additional Information Contact James B. Anderson
Manufacturer Reason
for Recall
Formulation deviation
FDA Determined
Cause 2
Mixed-up of materials/components
Action Amerx Health Care Corporation sent an URGENT: DEVICE RECALL letter instructing consignees to examine their inventory and immediately determine if they have any of the Lot numbers on hand and to quarantine the product subject to recall. In addition, if they may have further distributed the product, please notify their customers and/or post the enclosed letter in a visible location for the customer to read. Customers with questions were instructed to call 800-448-9599 or email recall@amerxhc.com. For questions regarding this recall call 727-443-0530.
Quantity in Commerce 21,108
Distribution Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
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.