Events

Recall of Device Recall Novaplus Sheridan/HVT Cuffed, Murphy Eye 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
    30952
  • Event Risk Class
    Class 3
  • Event Number
    Z-0582-05
  • Event Initiated Date
    2005-01-14
  • Event Date Posted
    2005-03-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36882
  • 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
    Some of the primary labels have the internal diameter (id) and outer diameter (od) numbers reversed, i.E. id 10.9 mm and od 8.0 mm instead of the actual id 8.0 and od 10.9 mm, mislabeling the size of the tracheal tube.
  • Action
    The direct accounts were notified of the mislabeling by letter dated 1/14/05, sent via Federal Express, Next Business Day Delivery on the same date. The accounts were requested to return their inventories of the affected lot to Teleflex Medical/Hudson RCI, and to subrecall the lot from their customers.

Device

Device Recall Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube
  • Model / Serial
    Catalog number V5-10316, lot 1152181, expiry 10-2009
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Hudson RCI, Temecula, CA 92589-9020, Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm)
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2345 Waukegan Rd, Suite 120, Bannockburn IL 60015
  • Source
    USFDA