CanadaOlympus MAJ-1443 (Reusable Suction Valve) and MAJ-1444 (Air/Water Valve), all lot numbers, are affected and can be identified by those model numbers. They are no longer reprocessing compatible with the OER-Pro (OER-PRO) and OER-Elite (OER-ELITE) automated endoscope reprocessors and therefore cannot be high-level disinfected using those reprocessors. Owners should reprocess the valves by the methods described in the updated Instructions for Use and contact the manufacturer for additional information.
What's being recalled
Companies: Olympus Medical Systems Corp., 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507.
How to identify it
Affected products: Air/Water Valves; Lot or serial number: All lots.; Model or catalogue number: MAJ-1444
Affected products: Reusable Suction Valve; Lot or serial number: All lots.; Model or catalogue number: MAJ-1443
Affected products: Endoscope Reprocessor; Lot or serial number: All lots.; Model or catalogue number: OER-ELITE
Affected products: OER-Pro Endoscope Reprocessor; Lot or serial number: All lots.; Model or catalogue number: OER-PRO
The hazard
Olympus is informing that the MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OERPro and OER-Elite automated endoscope reprocessors. This means the MAJ-1443 and MAJ-1444 can no longer be high-level disinfected using the OER-Pro or the OER-Elite and must instead be reprocessed by methods described in updated IFU.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)