FDAFDA · Food and drugs·Recall number Z-2640-2014
Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. 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: JCA0086 through JCA0106.
- 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.