Custom Ultrasonics said today that the FDA lifted the recall on its endoscope reprocessors while the company looks to correct the violations that prompted the recall.
Ivyland, Pa.-based Custom Ultrasonics said the action allows its devices to remain in the field to clean and sterilize endoscopes, excluding a type called duodenoscopes that caused a string of deadly “superbug” infections.
In November 2015 the FDA ordered Custom Ultrasonics to recall all 2,800 of its automated endoscope reprocessors over “continued violations of federal law and a consent decree entered with the company in 2007.”
Custom Ultrasonics said the superbug outbreak was linked to design changes made by the duodenoscope manufacturers that were not approved by the FDA.
“No AERs, including those of CUI, have been shown to cause these serious infections,” the company said in a statement. “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.”
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.
In August 2015, 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.
