Recall Z-2130-2016— Custom Ultrasonics, Inc.
Class II · Terminated
Class II FDA medical device recall by Custom Ultrasonics, Inc., initiated 2016-05-06, terminated 2017-04-18. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Custom Ultrasonics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-06
- Terminated
- 2017-04-18
- Firm location
- Ivyland, PA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.