BEUDAMED
    FDA Enforcement Class II Terminated

    Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants.

    Recall: Z-0527-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0527-2014
    Event ID
    66862
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2013
    Initiation Date
    November 13, 2013
    Classification Date
    December 17, 2013
    Termination Date
    March 27, 2014
    Address
    15 Wells St, N/A, Southbridge, MA, 01550-4503, United States

    Description

    Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants.

    Reason

    KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.

    Code Info

    C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E

    Distribution

    Nationwide Distribution.

    Quantity

    141 units