Uretero-reno fiberscopes recalled due to inadequate channel drying
Aizu Olympus is recalling uretero-reno fiberscopes because the channel air drying process was not validated. A small percentage of repaired devices had residual water in the channels, creating a risk of contamination and infection.
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 recall of medical endoscopes due to unvalidated drying process that allows water to remain in channels, creating contamination and infection risk. No illnesses have been reported.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling uretero-reno fiberscopes in the following models: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, and URF-V3R. These devices are used for endoscopic diagnosis and treatment in the ureter and kidney.
The recall was initiated because the channel air drying process was not validated during product development. Following this inadequate validation, a small percentage of devices returned to customers after repair contained water remaining in the instrument channels. Water in the channels creates the potential for contamination that could lead to infection.
The affected devices have been distributed worldwide, with US nationwide distribution.
The recalled product
- Product
- Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Category
- Medical Device — Endoscope
- Hazard
- water-contamination
- infection-risk
- inadequate-drying
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 (6)
- Model Number (UDI-DI): URF-P7 (04953170403811)
- URF-P7R (04953170403835)
- URF-V2 (04953170343582)
- URF-V2R (04953170343612)
- URF-V3 (04953170403385)
- URF-V3R (04953170403392).
Distribution
Distributed nationwide across the United States.
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