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U.S. Department of Health and Human Services

Class 2 Device Recall Amerigel Hydrogel Saturated Gauze Dressing

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  Class 2 Device Recall Amerigel Hydrogel Saturated Gauze Dressing see related information
Date Initiated by Firm July 11, 2014
Date Posted September 12, 2014
Recall Status1 Terminated 3 on July 22, 2015
Recall Number Z-2639-2014
Recall Event ID 69083
510(K)Number K971918  
Product Classification Dressing, wound and burn, hydrogel w/drug and/or biologic - Product Code MGQ
Product Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002.

Wound management.
Code Information Lot codes: 05368, 05345, 09282, 10295, 12201, 12303, 12303, 12328, 13100, 13115, and 13180.
Recalling Firm/
Manufacturer		 Amerx Health Care Corp.
1300 S. Highland Avenue
Clearwater FL 33756
For Additional Information Contact James B. Anderson
727-443-0530
Manufacturer Reason
for Recall		 Not approved labeling claims (antimicrobial and autolytic debridement)
FDA Determined
Cause 2		 Labeling design
Action On July 21, 2014, Amerx Health Care Corporation telephoned all affected customers advising them of the recalled products. During the call the customers were instructed to: 1) Discontinue dispensing the lot(s) and promptly return via parcel post to the Clearwater facility. 2) If you dispose of the product on your own, provide proof of disposal. 3) You will be reimbursed by check or credit memo for returned or disposed goods and postage.
Quantity in Commerce 21,108 units
Distribution Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, 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, and WV, and the countries of 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.
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