URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno recall
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Why was URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno recalled?
Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.
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?
All serial numbers are affected.
- Product
- URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 3461 units distributed to US consignees
- Distribution
- Distributed Nationwide
- Recall date
- March 8, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)