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Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage

FDA Recall #Z-1864-2016 — Class II — December 23, 2015

Recall #Z-1864-2016 Date: December 23, 2015 Classification: Class II Status: Terminated

Product Description

Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage

Reason for Recall

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

Recalling Firm

Fujifilm Medical Systems U.S.A., Inc. — Wayne, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

94 units

Distribution

Nationwide Distribution.

Code Information

All distribution dates :3/2003-4/2016

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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