FDAFDA · Food and drugs·Recall number Z-2638-2014
Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
Published September 24, 2014 · Recall initiated: July 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Not approved labeling claims (antimicrobial and autolytic debridement)
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Amerx Health Care Corp.
- Distributor
- 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
- Lot codes: 3WD02, 3WD03, 3WD04, and 3WD05
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.