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

Recall Z-2718-2020 — Alaris Pump Module Model 8100, a modular infusion pump and monitoring system

U.S. FDA — Device Enforcement · United States · 2020-06-30 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2718-2020
Date of alert
2020-06-30
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
CareFusion 303, Inc.
Product category
device
Product type
Devices
Reported risk: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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