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FDA: Custom Ultrasonics distributed medical devices without approval for years

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Staff writer ▼ | November 17, 2015
The U.S. Food and Drug Administration (FDA) ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm's continued violations of federal law and a consent decree entered with the company in 2007.
Custom Ultrasonics
Health safety   Documented continued violations
The identified violations could result in an increased risk of infection transmission. The FDA ordered this recall under the terms of the consent decree.

The agency also issued a safety communication recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.

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 clearance and are used to wash and high-level disinfect endoscopes to decontaminate them between uses.

In 2012, under the terms of the consent decree, the FDA ordered Custom Ultrasonics to stop manufacturing and distributing all AER device models and components, and ordered their recall after the company failed to obtain FDA clearance following a significant change to the software operating system for one of its AERs.

After Custom Ultrasonics obtained clearance for the significant change to the software operating system, the cleared devices were permitted to remain on the market.

Since the 2012 order, the FDA has not authorized Custom Ultrasonics to resume manufacturing or distributing any AERs, though the company has continued to service them.

The FDA's most recent inspection of Custom Ultrasonics' facility in April 2015 documented continued violations.