| Class 2 Device Recall Amerigel | |
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 | K970133 K971918 |
Product Classification |
Dressing, wound and burn, hydrogel w/drug and/or biologic - Product Code MGQ
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MGQ
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