According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex, 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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, bronchial (w/wo connector) - Product Code BTS
  • Reason
    Customer complaints reporting that the cobb connector detached from the main connector prior to use.
  • Action
    Recall letters were sent on 11/21/2014 to consignees requesting them to discontinue use and quarantine the products. The letter includes a reply form to be returned. The letter to the distributors requested a sub-recall, and included a recall letter to be sent to their accounts.


  • Model / Serial
    Product Code 116101370  Batch Number 13KT12, 13LT04; Product Code 116101390  Batch Number 13KT18; Product Code 116101410  Batch Number 13FT12R, 13GT05, 13JT11, 13JT15; Product Code 116101-000350  Batch Numbers 14JT14; Product Code 116101-000370  Batch Numbers 13FT06, 13FT12, 13FT18, 13GT05, 13GT29, 13HT07, 13HT12, 13HT17, 13IT16, 13IT20R, 13JT08, 13JT21, 13KT12, 13KT18, 13LT04, 13LT14, 14AT08, 14BT14, 14BT15, 14CT11, 14CT16, 14DT10, 14DT15, 14DT19, 14DT24, 14ET10, 14ET11, 14ET22, 14FT04, 14FT05, 14FT10, 14FT13, 14GT10, 14GT11, 14GT15, 14GT21, 14HT17, 14IT05, 14IT11, 14JT09, 14JT14; Product Code 116101-000390  Batch Numbers 13FT06, 13FT12, 13GT05, 13GT23, 13GT29, 13HE35, 13HT17, 13IT05, 13IT16, 13IT20, 13IT20R, 13JT08, 13JT21, 13KT12, 13KT15, 13KT18, 13LT04, 13LT11, 14BT14, 14BT21, 14CT11, 14CT21, 14DT03, 14DT13, 14DT15, 14DT19, 14DT20, 14DT25, 14ET04, 14ET28, 14FT04, 14FT16, 14GT10, 14GT11, 14GT21, 14GT23R, 14HT17, 14HT23, 14HT24, 14IT08, 14JT09, 14JT12; Product Code 116101-000410 - Batch Number 13FT06, 13FT12, 13GT05, 13GT24, 13GT29, 13HT07, 13HT12, 13HT17, 13IT16, 13IT20R, 13JT08, 13JT11, 13JT15, 13JT21, 13KT12, 13KT15, 13KT23, 13LT08, 13LT14, 13LT18, 14AT20, 14BT21, 14CT11, 14CT16, 14CT20, 14DT13, 14DT19, 14ET05, 14ET10, 14ET28, 14FT13, 14FT16, 14GT15, 14GT18, 14GT21R, 14HT03, 14HT17, 14HT23, 14HT24, 14JT09
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago
  • Product Description
    Carlens Bronchial Double Lumen Tube Set (Left) Sterile
  • Manufacturer


  • Manufacturer Address
    Teleflex, Inc., 550 E Swedesford Rd Ste 400, Wayne PA 19087-1601
  • Manufacturer Parent Company (2017)
  • Source