Health product recall

Olympus Flushing Pump

Last updated

Summary

Product
Olympus Flushing Pump
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Olympus Flushing Pump

More than 10 numbers, contact manufacturer.

OFP-2

Issue

During product testing, Olympus identified an intermittent loss of function of the ofp-2 flushing pump caused by an internal component connection failure. in the event that the connection failure occurs, the ofp-2 device will return to or remain in the "off" condition and the operator will not be able to use the flushing function. Through its investigation, Olympus determined that this issue resulted from an alternate tool being used during the manufacturing of one (1) lot of the subject component. Olympus has received three (3) complaints that are potentially applicable to this issue. No adverse events have been reported.

Recall start date: September 20, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Keymed (Medical & Industrial Equipment) Ltd.
Stock Road, Southend-On-Sea, Essex, Great Britain, SS2 5QH
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76245

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