Events

Recall of Sheridan HVT, Cuffed, Uncuffed 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
    76133
  • Event Risk Class
    Class 2
  • Event Number
    Z-1177-2017
  • Event Initiated Date
    2016-10-18
  • Event Date Posted
    2017-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152271
  • 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, tracheal (w/wo connector) - Product Code BTR
  • Reason
    Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.
  • Action
    Teleflex sent an Medical Device Recall Notification letter dated October 18, 2016, to all affected customers. Customers were advised to immediately discontinue use and to quarantine product. The letter to distributors requested a sub-recall. Both letters included an acknowledgement form to be returned. Customers with questions were instructed to contact their local representative or Customer Service at 1-800-246-6990.

Device

Sheridan HVT, Cuffed, Uncuffed Tracheal Tube
  • Model / Serial
    Lots 73A1500461 & 73D1400082
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including AL, AZ, ARK, CA, CO, CT, FL, GA. HI, KS, KY, IL, IN, IA, LA, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV and Internationally to Canada, Chile, & Japan
  • Product Description
    Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 || A tracheal tube is inserted into a patients mouth or nose for airway management
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA