Maker of device in ‘superbug’ outbreak lacked FDA clearance

March 5, 2015 6:19 PM

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his undated file photo provided by the U.S. Food and Drug Administration shows the tip of an endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope, attached to a long tube, not shown. Cedars-Sinai Medical Center said on Wednesday, March 4, 2015, that four patients have been infected with a superbug linked to a contaminated medical scope. Its the second Los Angeles hospital to report infections from a superbug known as CRE. (AP Photo/U.S. Food and Drug Administration, File)

WASHINGTON — Federal health officials say that the manufacturer of a medical instrument at the center of a recent “superbug” outbreak in Los Angeles did not receive federal clearance to sell the device.

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