Reported Dec 23, 2015 · Terminated
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT,…
Fujifilm Medical Systems U.S.A., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujifilm Medical Systems U.S.A., Inc. · 10 Highpoint Dr · Wayne, NJ · 07470-7431
Is this the product you have?
- Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Product as published ED-200XUSerial Numbers: 6572042, 5511033 and H451107 ED-200XTSerial Number: 8681034 ED-250XTSerial Number: HD077A008 ED-310XUSerial Number: 8591013 ED-420XLSerial Numbers: 9711002, 2D071D016, 2D071D010, 2D071D029 and 2D071D026 ED-410XTSerial Numbers: 8691039, 8691034 and 7691022 ED-410XUSerial Numbers: 2D060D010, 2D060D003, 6602091 and 6602100 ED-450XLSerial Numbers: 6D075B023, 6D075B015, 1D075B029 and 6D075B020 ED-450XTSerial Numbers; 1D076A002, 1D076A011, 1D076A013, 1D076A043, 1D076A039, 6D076A020, 6D076A033, 6D076A039, 6D076A037, 6D076A030 and 6D076A051 - Amount recalled
- 79 units (US) and 985 units (Internationally)
Where it was sold
Why it was recalled
A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
This product could cause temporary or reversible health problems — stop using it.
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