Events

Recall of AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile || -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Amd-Ritmed, Inc..

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
    74368
  • Event Risk Class
    Class 2
  • Event Number
    Z-0727-2017
  • Event Initiated Date
    2016-06-08
  • Event Date Posted
    2016-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147286
  • 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,hydrophilic - Product Code NAC
  • Reason
    The lot of transparent dressing was found to be contaminated (not sterile) based on fda sampling and analysis.
  • Action
    URGENT: MEDICAL DEVICE RECALL Letter (dated 6/8/2016) was e-mailed to the consignees on 6/8/2016. The recall is being conducted to the retail level. For questions. please contact AMD Customer Service by phone at 1-800-445-0340 or by e-mail at contactus@amdritmed.com.

Device

AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./C...
  • Model / Serial
    Lot 68408, expiration date 2018¿05
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    NY, MA, VA, TN
  • Product Description
    AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile || -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
  • Manufacturer
    Amd-Ritmed, Inc.

Manufacturer

Amd-Ritmed, Inc.
  • Manufacturer Address
    Amd-Ritmed, Inc., 295 Fire Tower Dr, Tonawanda NY 14150-5833
  • Source
    USFDA