Home / Recalls / Amerx Health Care Corp. / Z-0498-2015

Z-0498-2015 Class II Terminated

Recalled by Amerx Health Care Corp. — Clearwater, FL

Recall Details

Product Type
Devices
Report Date
December 10, 2014
Initiation Date
September 26, 2014
Termination Date
October 3, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
79,677

Product Description

Amerigel Post-op Surgical Kits Wound management

Reason for Recall

Formulation deviation

Distribution Pattern

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.

Code Information

Model # A2002, Lot #s: JCA0086, JCA0087, JCA0088, JCA0089, JCA0090, JCA0091, JCA0092, JCA0093, JCA0094, JCA0095, JCA0096, JCA0097, JCA0098, JCA0099, JCA0100, JCA0101, JCA0102, JCA0103, JCA0104, JCA0105, 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-0499-2015 Class II — Amerigel Daily Dressing Packets Wound management (September 26, 2014)
  • Z-0500-2015 Class II — Amerigel Saturated Gauze Dressing Wound management (September 26, 2014)
  • Z-0497-2015 Class II — Amerigel Hydrogel Wound Dressing 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)