Events

Recall of Amerigel Hydrogel Wound Dressing

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
    69394
  • Event Risk Class
    Class 2
  • Event Number
    Z-0497-2015
  • Event Date Posted
    2014-12-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130408
  • 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
    Formulation deviation.
  • Action
    Amerx Health Care Corporation sent an URGENT: DEVICE RECALL letter instructing consignees to examine their inventory and immediately determine if they have any of the Lot numbers on hand and to quarantine the product subject to recall. In addition, if they may have further distributed the product, please notify their customers and/or post the enclosed letter in a visible location for the customer to read. Customers with questions were instructed to call 800-448-9599 or email recall@amerxhc.com. For questions regarding this recall call 727-443-0530.

Device

Amerigel Hydrogel Wound Dressing
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Amerigel Hydrogel Wound Dressing || 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