Medical device recalls Moderate risk

Hospira Inc. recalls Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices…

Recall date
February 6, 2013
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2722-2016
FDA classification
Class II
Brand / firm
Hospira Inc.
Sold / distributed
United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.

Why it was recalled

The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.

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