Home / Recalls / Amerx Health Care Corp. / Z-2249-2016

Z-2249-2016 Class II Terminated

Recalled by Amerx Health Care Corp. — Clearwater, FL

Recall Details

Product Type
Devices
Report Date
July 27, 2016
Initiation Date
May 20, 2016
Termination Date
December 14, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,993 Units

Product Description

Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.

Reason for Recall

Product did not meet specifications for Zinc Acetate (OOS).

Distribution Pattern

AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska. Bahrain & Colombia.

Code Information

Lot # 668

Other recalls by Amerx Health Care Corp.

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