Reported Jun 8, 2016 · Terminated
Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
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?
- Endoscope ED-450XL5 Operation ManualCleaning, Disinfection and Storage
- Lot codes and dates
- All distribution dates3/2003-4/2016
- Amount recalled
- 94 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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