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Z-2641-2014 Class II Terminated

Recalled by Amerx Health Care Corp. — Clearwater, FL

FDA device recall Z-2641-2014 was initiated by Amerx Health Care Corp. on July 11, 2014 and is designated Class II. Reason for recall: Not approved labeling claims (antimicrobial and autolytic debridement) The recall status is terminated (terminated July 22, 2015). Affected quantity: 1,740 units.

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: 1,740 units

Product Description

Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. 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: 2WD07.

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