FDAFDA · Food and drugs·Recall number Z-1861-2016
Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
Published June 8, 2016 · Recall initiated: December 23, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Distributor
- Nationwide Distribution.
- Lot
- All distribution dates :3/2003-4/2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.