Custom Ultrasonics System 83 Plus Endoscope Washer Recall Issued
Custom Ultrasonics is recalling System 83 Plus endoscope washer/disinfectors to warn customers not to use them for duodenoscopes until further notice.
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: The recall involves a high-risk medical device used for disinfection, and the agency classification is Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Custom Ultrasonics, Inc. is recalling the System 83 Plus Endoscope Washer/Disinfector. The device is designed for the simultaneous reprocessing of up to two flexible submersible endoscopes used in the gastrointestinal and/or pulmonary tracts. The recall involves 2,345 units distributed nationwide to 49 states and the District of Columbia.
The recall is issued to warn customers that the System 83 Plus should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice. The source text does not specify the underlying defect or report any illnesses or injuries associated with the device.
Customers who possess these units should stop using them for the reprocessing of duodenoscopes immediately. The recall covers all serial numbers of the affected product.
The recalled product
- Product
- The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
- Manufacturer
- Custom Ultrasonics, Inc.
- Hazard
- Affected units
- 2,345
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
Distribution
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