Tracheal Fiberscope Airway Management Devices Recalled for Inadequate Channel Drying
Aizu Olympus is recalling 65 tracheal fiberscope units worldwide due to an unvalidated air drying process. Moisture remaining in device channels after repair could allow contamination and pose an infection risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device used for critical airway management with potential for infection from water contamination in channels. No illnesses or injuries have been reported; the hazard is based on the potential risk from an unvalidated drying process.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling 65 tracheal fiberscope units (Model Numbers LF-DP, LF-GP, and LF-TP) used for airway management, including observation to access airway anatomy, endotracheal intubation, and endobronchial intubation. The devices have been distributed worldwide, including throughout the United States.
The recall is due to an unvalidated channel air drying process. A small percentage of scopes returned to customers after repair were found to have moisture remaining in their channels. Water in the channels has the potential for contamination that could lead to infection risk.
Affected healthcare providers and facilities using these devices should contact Aizu Olympus Co., Ltd. for guidance on identifying affected units and options for remediation or replacement.
The recalled product
- Product
- Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Hazard
- water-contamination
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number (UDI-DI): LF-DP (04953170136856)
- LF-GP (04953170061998)
- LF-TP (04953170317576).
Distribution
Distributed nationwide across the United States.
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