Events

Recall of Device Recall Rusch

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
    60583
  • Event Risk Class
    Class 2
  • Event Number
    Z-0517-2012
  • Event Initiated Date
    2011-12-02
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105882
  • 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
    Stylet, tracheal tube - Product Code BSR
  • Reason
    Complaints of difficulty removing stylet from the endotracheal tube and possible pvc sheath separation were received.
  • Action
    The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" letter dated December 2, 2011 to its Consignees/Customers. The letter described the product, problem and actions to be take. The customers were instructed to immediately discontinue use and quarantine any products with the listed catalog and lot numbers; return the product; complete and return the enclosed Immediate Attention Requested Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customer Service (a customer service representative will contact the customer with a returns good authorization number and provide instructions for the return of product to Teleflex medical), even if they have no affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall Rusch
  • Model / Serial
    Catalog numbers: 502501, Lot numbers: 10JG05, 10JG28, 10JG35, 10JG42, 10KG07, 10KG30, 10KE48, 10LG22, 10LG25, 11AG02, 11AG25, 11GE07, 11BG11, 11BE08, 11BE09, 11CG16, 11CG19, 11DE15, 11EE30, 11EE21, 11FE24, 11GE29, 11GE30 and 11GG41.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada and Europe.
  • Product Description
    Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600 Kamunting, Perak, Malaysia. || Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
  • Manufacturer
    Teleflex Medical

Manufacturer

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