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Karl Storz Endoscopy America Inc recalls Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the t
Recalled December 25, 2013 · FDA recall Z-0527-2014 · Karl Storz Endoscopy America
Hazard
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. · FDA Class II
Units
141 units
Sold at
Nationwide Distribution.
Description
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.
Product
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.
Manufacturer(s)
Karl Storz Endoscopy America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →