Events

Recall of Device Recall 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
    74249
  • Event Risk Class
    Class 2
  • Event Number
    Z-2249-2016
  • Event Initiated Date
    2016-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146967
  • 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
    Lubricant, patient - Product Code KMJ
  • Reason
    Product did not meet specifications for zinc acetate (oos).
  • Action
    Initial recall notification was sent to distributors, informing them of the voluntary recall and providing instructions on expanding the recall to the wholesale level. Distributors were instructed to identify recalled product in their inventory, quarantine any recalled product, and to complete and fax back a Recall Response Form. Contact information was provided for those with questions: 1-800-448-9599 and recall@amerxhc.com.

Device

Device Recall Amerigel Hydrogel Wound Dressing
  • Model / Serial
    Lot # 668
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska. Bahrain & Colombia.
  • Product Description
    Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
  • Manufacturer
    Amerx Health Care Corp.

Manufacturer

Amerx Health Care Corp.
  • Manufacturer Address
    Amerx Health Care Corp., 1300 S Highland Ave, Clearwater FL 33756-6519
  • Manufacturer Parent Company (2017)
    Procyon Corp.
  • Source
    USFDA