Events

Recall of Device Recall Stretch gauze

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

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
    73324
  • Event Risk Class
    Class 2
  • Event Number
    Z-1251-2016
  • Event Initiated Date
    2016-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143875
  • 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, compression - Product Code MHW
  • Reason
    Product does not meet sterility requirements based on fda analysis and tested positive for bacterium bacillus.
  • Action
    AMD Ritmed sent an Urgent - Medical Device Recall letter dated February 25, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to examine all stocks immediately to determine if any of the affected product is on hand. If so, please discontinue distributing the product immediately and promptly return. If customers further distributed any of the product, please immediately contact your accounts advise them of the recall situation, and have them return their outstanding recalled stocks to you. Return these stocks as indicated above. Please return the enclosed response form immediately providing the requested information by fax 1-866-871-3455 or by email: AMDCustomerservice@amdritmed.com. Customers with questions can call 1-800-445-0340 or email AMD Customer Service: AMDCustomerservice@amdritmed.com.

Device

Device Recall Stretch gauze
  • Model / Serial
    Lot 63927, expiration 2017-04
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including Puerto Rico and to the states of : DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.
  • Product Description
    IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use || To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities
  • Manufacturer
    Amd Ritmed

Manufacturer

Amd Ritmed
  • Manufacturer Address
    Amd Ritmed, 1200 Av 55e, Lachine Canada
  • Source
    USFDA