Amerx Health Care Corp.: Medical Device Recall in 2015 - (Recall #: Z-1797-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.

Product Classification:

Class II

Date Initiated: February 25, 2015

Date Posted: June 24, 2015

Recall Number: Z-1797-2015

Event ID: 71161

Reason for Recall:

Nonapproved labeling claims (Sterile)

Status: Terminated

Product Quantity: 6,491 units

Code Information:

ALL Lots - 11406, 11414, 12439, 12466, and 02521.

Distribution Pattern:

Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.

Voluntary or Mandated:

Voluntary: Firm initiated