The FDA today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors over “continued violations of federal law and a consent decree entered with the company in 2007.”
The agency said the violations could result in an increased risk of infection transmission.
The FDA said that the recall was under terms of the consent decree, and it issued a safety communication to urge health care facilities using the devices to transition to alternative methods for scope reprocessing as soon as possible.
The recall affects an estimated 2,800 AERs manufactured by Custom Ultrasonics in use in healthcare facilities throughout the U.S.
The FDA said the recall affects all Custom Ultrasonic AERs including its System 83 Plus, System 83 Plus 2 and System 83 Plus 9.
Custom Ultrasonics has been given 7 business days to respond to the FDA with a written recall proposal.
“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations. The FDA’s recall order stemmed from the company’s continued violations of federal law and the consent decree and is necessary to protect the public health,” FDA CDRH deputy director for science Dr. William Maisel said in a press release.
In 2012 the FDA ordered Custom Ultrasonics to stop manufacturing and distributing all AER device models and components and ordered a recall after Custom Ultrasonics failed to obtain FDA clearance for significant software changes for the devices.
Custom Ultrasonics obtained clearance for the change and was permitted to remain on the market, the FDA said, but has not been authorized to resume manufacturing or distributing the devices.
This year, the FDA inspected Custom ultrasonics facility and noted continued violations, including the “inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.”
The agency gave the company time to respond to the violations it noted, and after reviewing the company’s submissions, it determined it had not adequately addressed the issues and ordered the recall.
In August, the FDA published warning letters it sent earlier this month to the 3 largest makers of endoscopes on the U.S. market, cautioning the companies about violations found during spring inspections at plants in the U.S. and Japan.
The inspections followed a string of deadly “superbug” infections attributed to duodenoscopes made by Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya‘s (TYO:7741) Pentax subsidiary. The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More than 500,000 ERCPs using the devices are performed in the U.S. annually.