BEUDAMED
    FDA Recall Terminated

    Bronchial One Lumen Tube - Right

    Recall: Z-2410-2015 · Initiated November 21, 2014

    Recall

    Recall Number
    Z-2410-2015
    Event Number
    71727
    Firm
    Teleflex, Inc.
    FEI Number
    3011369183
    Product Code
    BTS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 21, 2014
    Posted
    August 18, 2015
    Terminated
    August 15, 2017
    Address
    550 E Swedesford Rd, Ste 400, Wayne, PA, 19087-1601

    Description

    Bronchial One Lumen Tube - Right

    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.

    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