IVYLAND, Pa., May 16, 2016 /PRNewswire/ -- Custom Ultrasonics, Inc. (CUI) is pleased to announce that the Food & Drug Administration (FDA) is allowing Custom Ultrasonics Automated Endoscope Reprocessors (AERs) to remain in the field to clean and disinfect endoscopes, with the exception of duodenoscopes.
The FDA's recall notice of November 11, 2015 that was reinforced on January 26, 2016 has been modified such that Custom Ultrasonics' AER is not subject to removal while the corrective action is being implemented. Removal of the product has been replaced with a new warning that the AER should not be used on a specific type of endoscope, specifically duodenoscopes until further notice.
The FDA recalled the AER in November 2015, after a series infection outbreaks linked to duodenoscopes. The root cause analysis performed by outside third parties has implicated the "elevator or lifter" mechanism of these duodenoscopes, which were marketed without FDA clearance. No AERs, including those of CUI, have been shown to cause these serious infections.
The FDA has been working with medical device manufacturers, including Custom Ultrasonics, to develop improved procedures and protocols to assure that duodenoscopes can be safely reprocessed.
CUI is committed to continuing its pioneering role as a medical device manufacturer in endoscope reprocessing and improving safety for endoscopy patients.
About Custom Ultrasonics, Inc.: Custom Ultrasonics, Inc. is a medical device manufacturer that provides dependable high quality products to clean, high level disinfect endoscopes. CUI was established in 1978 by Frank Weber to design, manufacture and distribute automated systems to high-level disinfect complex devices including multi-channeled flexible endoscopes.
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SOURCE Custom Ultrasonics, Inc.