Events

Recall of Device Recall Conforming Stretch Gauze Bandages, Sterile

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
    73696
  • Event Risk Class
    Class 2
  • Event Number
    Z-2213-2016
  • Event Initiated Date
    2016-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144770
  • 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
    Bandage, elastic - Product Code FQM
  • Reason
    The product lot did not meet sterility requirements based on fda sampling and analysis.
  • Action
    The firm, AMD-Ritmed, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 3/30/2016 and Medical Device Recall Response Form to the US distributors/customers via e-mail. The letter described the product, problem and actions to be taken. The customers were instructed to examine your stock to determine if you have any; immediately discontinue distributing product; promptly return product via parcel post to Tonawanda/Buffalo warehouse, ATTENTION: RETURNED GOODS, AMD-Ritmed Inc., 295 Firetower Drive, Tonawanda, NY 14150; if you have further distributed the product, immediately contact your accounts, advise them of the recall situation and have them return their outstanding stock, and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE-Acknowledgment & Receipt Form via email to : AMDCUSTOMERSERVICE@AMDRITMED.COM or fax to: 1-866-871-3455, ATTN: AMD-Ritmed Customer Service. If you have any questions, please contact us at (1-800-445-0340) or at AMD Customer Service AMDCustomerService@amdritmed.com.

Device

Device Recall Conforming Stretch Gauze Bandages, Sterile
  • Model / Serial
    Lot 64155, Expiration Date 2017-06
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution in states of: NY, CA, and TN.
  • Product Description
    AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. || Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.
  • Manufacturer
    Amd-Ritmed, Inc.

Manufacturer

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