Amerigel Hydrogel Wound Dressing Wound management
This recall has been terminated (originally issued December 4, 2014).
- Company
- Amerx Health Care Corp.
- Recall Initiated
- September 26, 2014
- Posted
- December 4, 2014
- Terminated
- October 3, 2016
- Recall Number
- Z-0497-2015
- Quantity
- 340,896
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Formulation deviation
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 Internationally to: Canada, England, Africa, and Australia.
Lot / Code Info
Model # A2001, Lot #s: YWD13, YWD15, YWD16, 2WD01, 2WD02, 2WD03, 2WD04, 2WD05, 2WD08, 2WD09, 2WD11, 2WD13, 2WD14, 2WD15, 2WD17, 2WD18, 3WD01, 3WD02, 3WD03, 3WD04, 3WD05
Root Cause
Mixed-up of materials/components
Action Taken
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.