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

Recall Z-1360-2020 — CareFusion Alaris Pump Module, Model 8100

U.S. FDA — Device Enforcement · United States · 2020-02-04 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1360-2020
Date of alert
2020-02-04
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
CareFusion 303, Inc.
Product category
device
Product type
Devices
Reported risk: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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