Events

Recall of Device Recall Amerigel PostOp Surgical Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Amerx Health Care Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69083
  • Event Risk Class
    Class 2
  • Event Number
    Z-2640-2014
  • Event Initiated Date
    2014-07-11
  • Event Date Posted
    2014-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129598
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dressing, wound and burn, hydrogel w/drug and/or biologic - Product Code MGQ
  • Reason
    Not approved labeling claims (antimicrobial and autolytic debridement).
  • Action
    On July 21, 2014, Amerx Health Care Corporation telephoned all affected customers advising them of the recalled products. During the call the customers were instructed to: 1) Discontinue dispensing the lot(s) and promptly return via parcel post to the Clearwater facility. 2) If you dispose of the product on your own, provide proof of disposal. 3) You will be reimbursed by check or credit memo for returned or disposed goods and postage.

Device

Device Recall Amerigel PostOp Surgical Kits
  • Model / Serial
    Lot codes: JCA0086 through JCA0106.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages || CAT # A2002. || Wound management.
  • Manufacturer
    Amerx Health Care Corp.

Manufacturer

Amerx Health Care Corp.
  • Manufacturer Address
    Amerx Health Care Corp., 1300 S. Highland Avenue, Clearwater FL 33756
  • Manufacturer Parent Company (2017)
    Procyon Corp.
  • Source
    USFDA