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.”
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.”
