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U.S. Department of Health and Human Services

Class 2 Device Recall Amerigel PostOp Surgical Kits

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 Class 2 Device Recall Amerigel PostOp Surgical Kitssee related information
Date Initiated by FirmJuly 11, 2014
Date PostedSeptember 12, 2014
Recall Status1 Terminated 3 on July 22, 2015
Recall NumberZ-2640-2014
Recall Event ID 69083
510(K)NumberK971918 
Product Classification Dressing, wound and burn, hydrogel w/drug and/or biologic - Product Code MGQ
ProductAmerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.
Code Information Lot codes: JCA0086 through JCA0106.
Recalling Firm/
Manufacturer		 Amerx Health Care Corp.
1300 S. Highland Avenue
Clearwater FL 33756
For Additional Information ContactJames B. Anderson
727-443-0530
Manufacturer Reason
for Recall		Not approved labeling claims (antimicrobial and autolytic debridement)
FDA Determined
Cause 2		Labeling design
ActionOn 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 Commerce116,633 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = MGQ
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