Celon ProBreath and Celon ProSleep Applicators
Brand(s)
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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