Aizu Olympus Co., Ltd.: Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.

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: 1577 units Lot/code info: Model Number (UDI-DI): URF-P6 (04953170340802), URF-P6R (04953170340833).

UPC codes

04953170340802, 04953170340833

Source

Official record: FDA (Device enforcement) ↗

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