Z-0527-2014 Class II Terminated
FDA device recall Z-0527-2014 was initiated by Karl Storz Endoscopy America Inc on November 13, 2013 and is designated Class II. 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 the… The recall status is terminated (terminated March 27, 2014). Affected quantity: 141 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2013
- Initiation Date
- November 13, 2013
- Termination Date
- March 27, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 141 units
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.
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.
Distribution Pattern
Nationwide Distribution.
Code Information
C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E