Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1864-2016 — Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage

U.S. FDA — Device Enforcement · United States · 2015-12-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1864-2016
Date of alert
2015-12-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fujifilm Medical Systems U.S.A., Inc.
Product category
device
Product type
Devices
Reported risk: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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