Amerx Health Care Corp.: Medical Device Recall in 2014 - (Recall #: Z-2639-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.

Product Classification:

Class II

Date Initiated: July 11, 2014

Date Posted: September 24, 2014

Recall Number: Z-2639-2014

Event ID: 69083

Reason for Recall:

Not approved labeling claims (antimicrobial and autolytic debridement)

Status: Terminated

Product Quantity: 21,108 units

Code Information:

Lot codes: 05368, 05345, 09282, 10295, 12201, 12303, 12303, 12328, 13100, 13115, and 13180.

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.

Voluntary or Mandated:

Voluntary: Firm initiated