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

Z-2249-2016 Class II Terminated

Recalled by Amerx Health Care Corp. — Clearwater, FL

FDA device recall Z-2249-2016 was initiated by Amerx Health Care Corp. on May 20, 2016 and is designated Class II. Reason for recall: Product did not meet specifications for Zinc Acetate (OOS). The recall status is terminated (terminated December 14, 2016). Affected quantity: 6,993 Units.

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-0498-2015 Class II — Amerigel Post-op Surgical Kits Wound management (September 26, 2014)
Z-0499-2015 Class II — Amerigel Daily Dressing Packets Wound management (September 26, 2014)
Z-0497-2015 Class II — Amerigel Hydrogel Wound Dressing Wound management (September 26, 2014)
Z-0500-2015 Class II — Amerigel Saturated Gauze Dressing Wound management (September 26, 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)
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)