medical Class III Updated 2023-11-29

Aizu Olympus Co., Ltd. recalls Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P6

Recalled Product

Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number (UDI-DI): CHF-BP30 (04953170068751), CHF-CB30L (04953170340154), CHF-P60 (Not recorded).
View official government recall

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