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Olympus Corporation of the Americas Recall 89404

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

Olympus Corporation of the Americas Recall 89404 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0638-2022
Event ID89404
Event DescriptionOER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Product TypeDevices
DistributionNationwide
Quantity295 units
Recall ReasonThe 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
Device Classification20220223
Device Code InfoAll serial numbers. UDI: 04953170404047
Center Classification Date20220211
Recall Initiation Date20211213
Recalling FirmOlympus Corporation of the Americas
Initial Notification Letter
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