Home / Recalls / Amerx Health Care Corp. / Z-2640-2014

Z-2640-2014 Class II Terminated

Recalled by Amerx Health Care Corp. — Clearwater, FL

Recall Details

Product Type
Devices
Report Date
September 24, 2014
Initiation Date
July 11, 2014
Termination Date
July 22, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
116,633 units

Product Description

Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.

Reason for Recall

Not approved labeling claims (antimicrobial and autolytic debridement)

Distribution Pattern

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.

Code Information

Lot codes: JCA0086 through JCA0106.

Other recalls by Amerx Health Care Corp.

  • Z-2249-2016 Class II — Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. (May 20, 2016)
  • Z-1797-2015 Class II — Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. (February 25, 2015)
  • Z-0500-2015 Class II — Amerigel Saturated Gauze Dressing Wound management (September 26, 2014)
  • Z-0498-2015 Class II — Amerigel Post-op Surgical Kits Wound management (September 26, 2014)
  • Z-0497-2015 Class II — Amerigel Hydrogel Wound Dressing Wound management (September 26, 2014)
  • Z-0499-2015 Class II — Amerigel Daily Dressing Packets Wound management (September 26, 2014)
  • Z-2638-2014 Class II — Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. (July 11, 2014)
  • Z-2639-2014 Class II — Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2 (July 11, 2014)
  • Z-2641-2014 Class II — Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g (July 11, 2014)