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Recall Observatory FDA recall evidence

Device product

Amerigel Post-op Surgical Kits Wound management

Z-0498-2015

September 26, 2014

Class II

Product summary

Firm
Amerx Health Care Corp.
Event
Event 69394
Status
Terminated
Classification
Class II
Quantity
79,677
Official record key
device-enforcement:Z-0498-2015

Official wording

Reason: Formulation deviation

Code information: Model # A2002, Lot #s: JCA0086, JCA0087, JCA0088, JCA0089, JCA0090, JCA0091, JCA0092, JCA0093, JCA0094, JCA0095, JCA0096, JCA0097, JCA0098, JCA0099, JCA0100, JCA0101, JCA0102, JCA0103, JCA0104, JCA0105, JCA0106

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