Custom Ultrasonics has history of violating federal rules for manufacturing and quality control
MONDAY, Nov. 16, 2015 (HealthDay News) — Nearly 2,800 machines used to disinfect medical scopes are being recalled because they may put patients at risk for infections, the U.S. Food and Drug Administration says.
The agency ordered Custom Ultrasonics of Warminster, Pa., to recall all its endoscope reprocessing devices, which are used at hospitals and medical clinics nationwide, the Associated Press reported. The devices are meant to clean flexible endoscopes so they can be re-used safely, but Custom Ultrasonics has a history of violating federal rules for manufacturing and quality control, the FDA said.
The recall was ordered under terms of a 2007 legal agreement with the company that forbids it from making or distributing the endoscope reprocessing devices. Custom Ultrasonics has continued to service the devices, the AP reported. However, the FDA says the company still cannot prove that its devices adequately wash and disinfect endoscopes.
Hospitals and medical clinics with the Custom Ultrasonics devices should use other endoscope cleaning machines to reduce the risk of patient infections, the FDA said. A number of dangerous bacterial outbreaks associated with medical scopes have occurred at hospitals across the U.S., the AP reported.
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