Recall Z-0526-2014— Karl Storz Endoscopy America Inc
Class II · Terminated
Class II FDA medical device recall by Karl Storz Endoscopy America Inc, initiated 2013-11-13, terminated 2014-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Karl Storz Endoscopy America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-13
- Terminated
- 2014-03-27
- Firm location
- Southbridge, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.