Custom Ultrasonics Ordered to Recall Unsafe Medical Equipment
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Custom Ultrasonics Ordered to Recall Unsafe Medical Equipment

November 13, 2015

The Food and Drug Administration (FDA) is ordering Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to a continued risk of infection transmission stemming from unsafe products.

According to federal officials, the company has been operating in violation of federal law and a consent decree since 2007.

An estimated 2,800 AERs manufactured by Custom Ultrasonics are currently in hospitals and outpatient clinics throughout the United States. The FDA's recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9. Within seven business days after receiving the FDA's recall order, Custom Ultrasonics must provide a written recall proposal to the FDA.

AERs are Class II medical devices that require 510(k) clearance and are used to wash and high-level disinfect endoscopes to decontaminate them between uses. AERs are designed to expose outside surfaces as well as interior channels of endoscopes to chemical solutions in order to kill microorganisms and prevent the spread of infection from these reusable medical devices. An endoscope must be thoroughly cleaned to remove any visible debris prior to placing it in an AER, which includes manually scrubbing the elevator mechanism and the recesses surrounding the elevator mechanism.

The FDA's most recent inspection of Custom Ultrasonics' facility in April 2015 documented continued violations. Violations include the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.

The FDA recommends that medical facilities identify and transition to alternate methods to reprocess flexible endoscopes, such as manual high-level disinfection, liquid chemical sterilization, alternative AERs or other cleaning and sterilization methods according to the endoscope manufacturer's reprocessing instructions.