Health product recall

Celon ProBreath and Celon ProSleep Applicators

Last updated

Summary

Product
Celon ProBreath and Celon ProSleep Applicators
Issue
Medical devices - Labelling and packaging
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

Celon ProSleep Plus Bipolar Applicator

1000169653

WB990008

Celon ProSleep Plus

1000169656

WB990095

Celon ProBreath Bipolar Applicator

1000172949

WB990007

Celon ProBreath Bipolar Applicator

1000172947

WB990007

Celon ProBreath Bipolar Applicator

1000171773

WB990007

Celon ProBreath Bipolar Applicator

1000172948

WB990007

Celon ProBreath Bipolar Applicator

1000169475

WB990007

Issue

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Olympus Winter & Ibe Gmbh
Kuehnstrasse 61, Hamburg, Hamburg, Germany, 22045
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81630

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