FDA orders recall of all Custom Ultrasonic endoscope reprocessors

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 devic...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Recalls Regulatory/Compliance Custom Ultrasonics Source Type: news