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Recall Observatory FDA recall evidence

Device product

Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.

Z-2640-2014

July 11, 2014

Class II

Product summary

Firm
Amerx Health Care Corp.
Event
Event 69083
Status
Terminated
Classification
Class II
Quantity
116,633 units
Official record key
device-enforcement:Z-2640-2014

Official wording

Reason: Not approved labeling claims (antimicrobial and autolytic debridement)

Code information: Lot codes: JCA0086 through JCA0106.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Not approved labeling claims (antimicrobial and autolytic debridement)