Z-0526-2014 Class II Terminated
FDA device recall Z-0526-2014 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: 1516 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
- 1516 units
Product Description
Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. " Transoral intubation " Transnasal intubation " Evaluation of placement of endotracheal and double lumen endotracheal tubes " Provide visual access to the larynx and tracheobronchial tree.
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