Events

Recall of Device Recall Sheridan Preformed Cuffed Tracheal Tube

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

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
    52782
  • Event Risk Class
    Class 2
  • Event Number
    Z-1890-2009
  • Event Initiated Date
    2009-07-06
  • Event Date Posted
    2009-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83993
  • 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
    Tracheal Tube - Product Code BTR
  • Reason
    The nasal preformed tracheal tubes were found to have incorrect insertion depth mark printings.
  • Action
    Consignees were notified by an Urgent Medical Device Recall letter on/about 07/06/2009. They were instructed to discontinue use of and return any of the recalled product to Teleflex Medical. Distributors were advised to forward the letter to their consignees to retrieve relevant product from those locations. A Recall Acknowledgement Form was attached to be returned to Teleflex Medical. Replacement product or credit will be provided to the consignee.

Device

Device Recall Sheridan Preformed Cuffed Tracheal Tube
  • Model / Serial
    Lot number 01A0900364
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of CA, FL, IL, KY, MA, NC, NM, NJ, OH, PA, RI, TN, TX, UT, VA, WA, and WI and countries of France and Japan.
  • Product Description
    Sheridan Preformed Cuffed Tracheal Tube, Nasal 6.5, Catalog Number: 5-22313, Teleflex Medical Ltd, Research Triangle Park, NC 27709 || Used for oral or nasal intubation for airway management.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA