Aizu Olympus Co., Ltd.: Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.

Hazard

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Details from the source

Reason for recall: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection Distribution: Worldwide - US Nationwide distribution. Quantity: N/A Lot/code info: Model Number (UDI-DI): URF-P7 (04953170403811), URF-P7R (04953170403835), URF-V2 (04953170343582), URF-V2R (04953170343612), URF-V3 (04953170403385), URF-V3R (04953170403392).

UPC codes

04953170403811, 04953170403835, 04953170343582, 04953170343612, 04953170403385, 04953170403392

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.