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Recall Observatory FDA recall evidence

Device product

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

Z-1797-2015

February 25, 2015

Class II

Product summary

Firm
Amerx Health Care Corp.
Event
Event 71161
Status
Terminated
Classification
Class II
Quantity
6,491 units
Official record key
device-enforcement:Z-1797-2015

Official wording

Reason: Nonapproved labeling claims (Sterile)

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Nonapproved labeling claims (Sterile)