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Recall Observatory FDA recall evidence

Device product

Amerigel Hydrogel Wound Dressing Wound management

Z-0497-2015

September 26, 2014

Class II

Product summary

Firm
Amerx Health Care Corp.
Event
Event 69394
Status
Terminated
Classification
Class II
Quantity
340,896
Official record key
device-enforcement:Z-0497-2015

Official wording

Reason: Formulation deviation

Code information: Model # A2001, Lot #s: YWD13, YWD15, YWD16, 2WD01, 2WD02, 2WD03, 2WD04, 2WD05, 2WD08, 2WD09, 2WD11, 2WD13, 2WD14, 2WD15, 2WD17, 2WD18, 3WD01, 3WD02, 3WD03, 3WD04, 3WD05

Distribution pattern: Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, 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, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Formulation deviation