Choledochoscope Intended to provide optical recall
Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted…
Why was Choledochoscope Intended to provide optical recalled?
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
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?
Model #'s FCP-8P and FCP-9P
- Product
- Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted…
- Recalling firm
- Pentax Medical Company
- Quantity
- 50 units
- Distribution
- Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
- Recall date
- July 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)