BEUDAMED
    FDA Enforcement Class II Terminated

    Carlens Bronchial Double Lumen Tube Set (Left) Sterile

    Recall: Z-2411-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2411-2015
    Event ID
    71727
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2015
    Initiation Date
    November 21, 2014
    Classification Date
    August 19, 2015
    Termination Date
    August 15, 2017
    Address
    550 E Swedesford Rd Ste 400, Wayne, PA, 19087-1601, United States

    Description

    Carlens Bronchial Double Lumen Tube Set (Left) Sterile

    Reason

    Customer complaints reporting that the cobb connector detached from the main connector prior to use.

    Code Info

    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

    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