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OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive...

FDA Recall #Z-0638-2022 — Class II — December 13, 2021

Recall #Z-0638-2022 Date: December 13, 2021 Classification: Class II Status: Terminated

Product Description

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories

Reason for Recall

The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent

Recalling Firm

Olympus Corporation of the Americas — Center Valley, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

295 units

Distribution

Nationwide

Code Information

All serial numbers. UDI: 04953170404047

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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