Olympus Recalls Celon ProBreath and Celon ProSleep Applicators Due to Missing Instructions
Olympus has issued a recall for specific lots of Celon ProBreath and Celon ProSleep Plus bipolar applicators because they were distributed without the required Instructions for Use (IFU).
What Happened
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. This documentation is necessary for the proper operation and handling of the medical devices.
Which Products Are Affected
The recall involves the following products manufactured by Olympus Winter & Ibe Gmbh:
- Celon ProSleep Plus Bipolar Applicator: Model WB990008, Lot/Serial 1000169653
- Celon ProSleep Plus: Model WB990095, Lot/Serial 1000169656
- Celon ProBreath Bipolar Applicator: Model WB990007, Lots/Serials 1000172949, 1000172947, 1000171773, 1000172948, and 1000169475
What You Should Do
Users who have purchased these products should immediately contact the Olympus Canada Technical Assistance Center (TAC) to obtain the missing Instructions For Use. Once the IFU is received, users must ensure a copy is placed with the device for reference by medical staff.
Why This Matters
Instructions for Use are critical for ensuring that medical devices are used safely and according to the manufacturer’s specifications. The absence of these instructions could lead to improper use of the bipolar applicators.
Source
For more information, visit the official Health Canada recall notice.
Source: Health Canada Official Notice