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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00680-1
Product Name/Description Olympus OFP-2 Flushing Pump (used with endoscopic irrigation)

Multiple Lot Numbers affected.

ARTG Number: 145859
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 11/07/2013
Responsible Entity Olympus Australia Pty Ltd
Reason/Issue Olympus has received a small number of reports where the pump may be supplied with the pump head in the unlocked position. If the pump head is unlocked, this may cause the pump to stop and go into stand-by mode. As a result, no water will be delivered to the endoscope.
Recall Action Recall for Product Correction
Recall Action Instructions Olympus are requesting users to discontinue use of the affected devices. An Olympus Field Service Technician will perform an inspection and modification if required. Olympus is also providing inspection and modification instructions should the end user wish to correct the device.
At the time of agreement 17 customers had received the correction. These customers have been provided with the product correction information for their records.
Contact Information 03 9265 5429 - Olympus Quality Assurance