Recall Z-0497-2015 ยท MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Amerx Health Care Corp.
Amerigel Hydrogel Wound Dressing Wound management
| Date | Dec 4, 2014 (initiated Sep 26, 2014) |
| Status | Terminated |
| Reason | Formulation deviation |
| Root cause | Mixed-up of materials/components |
| Action | Amerx Health Care Corporation sent an URGENT: DEVICE RECALL letter instructing consignees to examine their inventory and immediately determine if they have any of the Lot numbers on hand and to quarantine the product subject to recall. In addition, if they may have further distributed the product, please notify their customers and/or post the enclosed letter in a visible location for the customer to read. Customers with questions were instructed to call 800-448-9599 or email recall@amerxhc.com. For questions regarding this recall call 727-443-0530. |
| Quantity | 340,896 |
| Distribution | Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, 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, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971918 | AMERIGEL OINTMENT SATURATED WOUND DRESSING Amerx Health Care Corp., Aug 12, 1997 |