Events

Recall of Device Recall Amerigel

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
    71161
  • Event Risk Class
    Class 2
  • Event Number
    Z-1797-2015
  • Event Initiated Date
    2015-02-25
  • Event Date Posted
    2015-06-12
  • 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=136323
  • 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
    Nonapproved labeling claims (sterile).
  • Action
    On March 9, 2015 the firm contacted its customers via telephone. Within that conversation the firm asked its customers to examine their inventory to determine if they have any of the affected lot numbers on hand and notify the firm for an immediate product substitution, credit or refund. Customers were asked to discontinue dispensing any product on hand, and notify any customers that the product may have been further distributed to. The firm also asked that the response form be completed and returned. If no contact was made via telephone, the firm sent a certified letter asking the firm(s) to do the same actions as the phone request. If you have any questions please call 1-800-448-9599 or e-mail marketcorrection@amerxhc.com.

Device

Device Recall Amerigel
  • Model / Serial
    ALL Lots - 11406, 11414, 12439, 12466, and 02521.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
  • Product Description
    Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. || 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