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Fujifilm Medical Systems U.S.A., Inc. recalls Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
Recalled June 8, 2016 · FDA recall Z-1864-2016 · Fujifilm Medical Systems U.S.A
Hazard
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures. · FDA Class II
Units
94 units
Sold at
Nationwide Distribution.
Description
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Product
Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →