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Recall Observatory FDA recall evidence

Device product

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

Z-0330-2024

September 25, 2023

Class III

Product summary

Firm
Aizu Olympus Co., Ltd.
Event
Event 93222
Status
Ongoing
Classification
Class III
Quantity
3 units
Official record key
device-enforcement:Z-0330-2024

Official wording

Reason: 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

Code information: Model Number (UDI-DI): CHF-BP30 (04953170068751), CHF-CB30L (04953170340154), CHF-P60 (Not recorded).

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    contamination that could lead