FDAFDA · Food and drugs·Recall number Z-0500-2015
Amerigel Saturated Gauze Dressing Wound management
Published December 10, 2014 · Recall initiated: September 26, 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
Formulation deviation
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 - 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
- Model # A5002, Lot #s: 05368, 05345, 09282, 10295, 12201, 12303, 12322, 12328, 13100, 13115, 13180
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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