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The Food and Drug Administration (FDA) has ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from healthcare facilities due to what the FDA says is “the firm’s continued violations of federal law.”
“The identified violations could result in an increased risk of infection transmission,” according to the FDA.
The agency recommends that healthcare facilities using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible. Custom Ultrasonics was required to provide a written recall proposal to the FDA within seven business days of the announcement.
Facilities using the AER should report any infections that might be related to the recalled reprocessors to the company and the FDA MedWatch program. (Access MedWatch at http://1.usa.gov/1ghByT7. For the announcement, go to http://1.usa.gov/1SfhLEW. For background, see “Custom Ultrasonics resumes manufacturing,” SDS, September 2007.)