Intubation Flexible Fiberscope recall
Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. " Transoral…
Why was Intubation Flexible Fiberscope recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E
- Product
- Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. " Transoral…
- Recalling firm
- Karl Storz Endoscopy America Inc
- Quantity
- 1516 units
- Distribution
- Nationwide Distribution.
- Recall date
- December 25, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)