Olympus BF-MP60 Bronchofiberscope Recall: Updated Sterilization and Reprocessing Instructions
Olympus is updating instructions for reprocessing and sterilizing BF-MP60 bronchofiberscopes to ensure proper procedures. All 60 units distributed nationwide are affected.
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: This is an FDA Class II recall for a risk-of-harm medical device (respiratory endoscope) where improper sterilization and reprocessing could lead to cross-contamination and patient infection. Although no illnesses or injuries have been reported, the critical nature of proper device reprocessing and sterilization for patient safety justifies a High severity rating.
Plain-English summary
Olympus Corporation of the Americas is issuing updated instructions for the BF-MP60: OES Bronchofiberscope, a respiratory medical device. The update addresses procedures for chemical use during device reprocessing, conditions for ethylene oxide (ETO) gas sterilization, rinsing steps following high-level disinfection, and sterilization recommendations.
Approximately 60 units of this device have been distributed nationwide in the United States. All serial numbers are affected by this instruction update, as identified by UDI 04953170339394.
Healthcare facilities and medical professionals using this device should review and implement the updated instructions to ensure proper reprocessing and sterilization procedures are followed. Adherence to proper sterilization and reprocessing protocols is essential to prevent cross-contamination and ensure patient safety.
The recalled product
- Product
- BF-MP60: OES Bronchofiberscope
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- improper-sterilization
- cross-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 (1)
- All serial numbers. UDI: 04953170339394
Distribution
Distributed nationwide across the United States.
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