Events

Recall of Device Recall Custom Made Tracheostomy Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD, 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
    79045
  • Event Risk Class
    Class 2
  • Event Number
    Z-0577-2018
  • Event Initiated Date
    2016-07-15
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161230
  • 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
    Tube tracheostomy and tube cuff - Product Code JOH
  • Reason
    Smiths medical determined that a single custom tracheostomy device had been shipped to the customer without required sterilization.
  • Action
    The firm, Smith Medical, notified the consignee by phone on July 29, 2017 of the Field Corrective Action Report. The consignee was instructed to return the devices for destruction and replacement. If you have any questions, contact VP, Global Quality and Regulatory at 219-989-9150.

Device

Device Recall Custom Made Tracheostomy Device
  • Model / Serial
    GS025081
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Distribution to:Germany
  • Product Description
    Custom Made Tracheostomy Device || The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 5700 W 23rd Ave, Gary IN 46406-2617
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA