FDAClass IIJune 8, 2016

Endoscope ED-250XT5 Operations Manual: Cleaning recall

Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage

Why was Endoscope ED-250XT5 Operations Manual: Cleaning recalled?

This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All distribution dates :3/2003-4/2016

Product
Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
Recalling firm
Fujifilm Medical Systems U.S.A., Inc.
Quantity
882 units
Distribution
Nationwide Distribution.
Recall date
June 8, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls