VISERA Tracheal Intubation Videoscope OLYMPUS LF Type recall: Labeling Error
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy…
Why was VISERA Tracheal Intubation Videoscope OLYMPUS LF Type recalled?
Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 04953170340246 All serial numbers
- Product
- VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1433 units
- Distribution
- Nationwide
- Recall date
- August 16, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)