CanadaCertain Celon ProBreath and Celon ProSleep Plus bipolar applicators (models WB990007, WB990008, WB990095; lot/serial numbers 1000169653, 1000169656, 1000169475, 1000171773, 1000172947, 1000172948, 1000172949) are affected. They were released to customers without the required Instructions For Use (IFU); users should obtain the IFU through the Olympus Canada Technical Assistance Center (TAC) and ensure a copy is placed with the device. Contact the manufacturer for additional information.
What's being recalled
Companies: Olympus Winter & Ibe Gmbh, Kuehnstrasse 61, Hamburg, Hamburg, Germany, 22045.
How to identify it
Affected products: Celon ProSleep Plus Bipolar Applicator; Lot or serial number: 1000169653; Model or catalogue number: WB990008
Affected products: Celon ProSleep Plus; Lot or serial number: 1000169656; Model or catalogue number: WB990095
Affected products: Celon ProBreath Bipolar Applicator; Lot or serial number: 1000172949; Model or catalogue number: WB990007
Affected products: Celon ProBreath Bipolar Applicator; Lot or serial number: 1000172947; Model or catalogue number: WB990007
Affected products: Celon ProBreath Bipolar Applicator; Lot or serial number: 1000171773; Model or catalogue number: WB990007
Affected products: Celon ProBreath Bipolar Applicator; Lot or serial number: 1000172948; Model or catalogue number: WB990007
Affected products: Celon ProBreath Bipolar Applicator; Lot or serial number: 1000169475; Model or catalogue number: WB990007
The hazard
Olympus has identified that certain boxes of Celon ProBreath and Celon ProSleep Plus bipolar applicators were released to customers without the required Instructions For Use (IFU) included. Users should obtain the IFU through Olympus Canada Technical Assistance Center (TAC) and ensure a copy of the IFU is placed with the device.
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)