FDA orders recall of machine used to clean medical scopes
WASHINGTON (AP) — Federal officials are ordering the recall of nearly 2,800 machines used to disinfect medical scopes, due to company violations that could lead to infections in patients.
The Food and Drug Administration says Custom Ultrasonics must recall all of its endoscope reprocessing devices, which are currently used at hospitals and medical clinics throughout the U.S. The agency ordered the action under a 2007 legal settlement with the company, which bars it from making or distributing the machines. Custom Ultrasonics continues to service the machines.
But FDA inspectors uncovered additional problems with the company's technology during an April inspection.
The FDA says hospitals and medical facilities should switch to alternate machines to avoid possible infections.
The announcement follows a series of life-threatening bacterial outbreaks that have been tied to medical scopes.