Recall Z-1797-2015 ยท MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Amerx Health Care Corp.
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
| Date | Jun 12, 2015 (initiated Feb 25, 2015) |
| Status | Terminated |
| Reason | Nonapproved labeling claims (Sterile) |
| Root cause | 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) |
| Quantity | 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. |
| FDA record | Open on fda.gov |