Aizu Olympus Co., Ltd.: Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.

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: 3 units Lot/code info: Model Number (UDI-DI): CHF-BP30 (04953170068751), CHF-CB30L (04953170340154), CHF-P60 (Not recorded).

UPC codes

04953170068751, 04953170340154

Source

Official record: FDA (Device enforcement) ↗

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