FDA (Devices) recall action 73469
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Fujifilm Medical Systems is recalling 882 ED-250XT5 endoscope operations manuals following reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
Fujifilm Medical Systems is correcting the operation manual for the ED-450XL5 endoscope to address publicized reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
Fujifilm Medical Systems is correcting the ED-530XT endoscope manual to address reports of multi-drug resistant bacteria found on endoscopes used in ERCP procedures.
Fujifilm Medical Systems is correcting the ED-250XL5 endoscope operations manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
Fujifilm Medical Systems is correcting the ED-450XT5 endoscope manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.