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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product 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.
Recall Number Z-0527-2014
Classification Class II
Code Info C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E
Product Distributed Qty 141 units
Reason For Recall 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.

Event Detail

Event Id 66862
Product Type Devices
Status Ongoing
Recalling Firm Karl Storz Endoscopy America Inc
City Southbridge
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.