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Health product recall

OER-PRO ENDOSCOPE REPROCESSOR (2016-06-16)

Starting date:
June 16, 2016
Posting date:
July 19, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, Hospitals, General Public
Identification number:
RA-59400

Affected products

A. OER-PRO ENDOSCOPE REPROCESSOR

Reason

OER-Pro operation manual has been revised to add a new warning requiring users to conduct precleaning and manual cleaning as detailed in the duodenoscope's reprocessing manual(s).

Affected products

A. OER-PRO ENDOSCOPE REPROCESSOR

Lot or serial number

All lots

Model or catalog number

OER-PRO

Companies
Manufacturer
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN