Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
This recall has been terminated (originally issued September 12, 2014).
- Company
- Amerx Health Care Corp.
- Recall Initiated
- July 11, 2014
- Posted
- September 12, 2014
- Terminated
- July 22, 2015
- Recall Number
- Z-2638-2014
- Quantity
- 382,620 units
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Not approved labeling claims (antimicrobial and autolytic debridement)
Distribution
Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, 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, and WV, and the countries of Canada, England, Africa, and Australia.
Lot / Code Info
Lot codes: 3WD02, 3WD03, 3WD04, and 3WD05
Root Cause
Labeling design
Action Taken
On July 21, 2014, Amerx Health Care Corporation telephoned all affected customers advising them of the recalled products. During the call the customers were instructed to: 1) Discontinue dispensing the lot(s) and promptly return via parcel post to the Clearwater facility. 2) If you dispose of the product on your own, provide proof of disposal. 3) You will be reimbursed by check or credit memo for returned or disposed goods and postage.