Home / Recalls / Amerx Health Care Corp. / Z-1797-2015

Z-1797-2015 Class II Terminated

Recalled by Amerx Health Care Corp. — Clearwater, FL

Recall Details

Product Type
Devices
Report Date
June 24, 2015
Initiation Date
February 25, 2015
Termination Date
October 3, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,491 units

Product Description

Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.

Reason for Recall

Nonapproved labeling claims (Sterile)

Distribution Pattern

Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.

Code Information

ALL Lots - 11406, 11414, 12439, 12466, and 02521.

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-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)
  • Z-2640-2014 Class II — Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerige (July 11, 2014)