The rare recall order comes as a result of a consent-decree violation by the company, which supplies endoscope reprocessors to almost 3,000 hospitals nationwide. FDA says Custom Ultrasonics has failed to validate its device designs, among other concerns.
FDA has ordered Custom Ultrasonics Inc. to recall of its Automated Endoscope Reprocessors (AERs) from health care facilities because the company is in violation of a 2007 consent decree, the agency announced Nov. 13.
FDA estimates 2,800 AERs manufactured by Custom Ultrasonics are now being used in hospitals and outpatient clinics throughout the United States
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.
A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
