FDAFDA · Food and drugs·Recall number Z-0526-2014
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.
Published December 25, 2013 · Recall initiated: November 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Karl Storz Endoscopy America Inc
- Distributor
- Nationwide Distribution.
- Lot
- C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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