Events

Recall of Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100 (MD-04002). Sterile. Single Use.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Device Group 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
    32468
  • Event Risk Class
    Class 2
  • Event Number
    Z-1371-05
  • Event Initiated Date
    2005-06-08
  • Event Date Posted
    2005-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40143
  • 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
    Accessory To Continuous Ventilator (Respirator) - Product Code MOD
  • Reason
    Device separation presenting a choking hazard.
  • Action
    Distributors were contacted by telephone on June 8, 2005, distributors were requested to return product. Letters were also sent by mail with proof of reciept on June 10, 2005. Firm reports that all customers have been notified.

Device

Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100 (MD-04002). Steri...
  • Model / Serial
    Lot 2005001
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Brasil and Canada
  • Product Description
    Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100 (MD-04002). Sterile. Single Use.
  • Manufacturer
    Medical Device Group Inc.

Manufacturer

Medical Device Group Inc.
  • Manufacturer Address
    Medical Device Group Inc., 12675 Stowe Dr Ste B, Poway CA 92064-8848
  • Source
    USFDA