Reported Jul 13, 2016 · Terminated
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible…
Custom Ultrasonics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Custom Ultrasonics, Inc. · 144 Railroad Dr · Ivyland, PA · 18974-1449
Is this the product you have?
- 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.
- Lot codes and dates
- All serial numbers
- Amount recalled
- 2,345 units
Where it was sold
Why it was recalled
To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.
This product could cause temporary or reversible health problems — stop using it.
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