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U.S. Department of Health and Human Services

Class 2 Device Recall Amerigel

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  Class 2 Device Recall Amerigel see related information
Date Initiated by Firm February 25, 2015
Date Posted June 12, 2015
Recall Status1 Terminated 3 on October 03, 2016
Recall Number Z-1797-2015
Recall Event ID 71161
510(K)Number K971918  K970133  
Product Classification Dressing, wound and burn, hydrogel w/drug and/or biologic - Product Code MGQ
Product Amerigel Hydrogel Gauze Dressing 2 x 2, A5002.

Wound Management.
Code Information ALL Lots - 11406, 11414, 12439, 12466, and 02521.
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		 Nonapproved labeling claims (Sterile)
FDA Determined
Cause 2		 Labeling False and Misleading
Action On March 9, 2015 the firm contacted its customers via telephone. Within that conversation the firm asked its customers to examine their inventory to determine if they have any of the affected lot numbers on hand and notify the firm for an immediate product substitution, credit or refund. Customers were asked to discontinue dispensing any product on hand, and notify any customers that the product may have been further distributed to. The firm also asked that the response form be completed and returned. If no contact was made via telephone, the firm sent a certified letter asking the firm(s) to do the same actions as the phone request. If you have any questions please call 1-800-448-9599 or e-mail marketcorrection@amerxhc.com.
Quantity in Commerce 6,491 units
Distribution Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
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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