Agency classClass IIOur severity:High FDA (Devices)·Z-2723-2016·Announced 2016-09-14

Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the delay or interruption of therapy, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Hospira Inc. is recalling 357,778 units of the Plum A+ Infusion Pump (List Number 11971). The recall is due to a defect where the fluid shield diaphragm is undersized. This defect may result in alarms or the delay or interruption of therapy.

The affected devices were distributed nationwide in the United States, including Puerto Rico and the U.S. Virgin Islands, as well as in Costa Rica, Turks and Caicos, and the Dominican Republic. The recall covers specific serial numbers listed in the official FDA record Z-2723-2016.

Healthcare facilities and users should check their inventory for the affected serial numbers and contact Hospira Inc. for further instructions on the recall.

The recalled product

Product: Plum A+ Infusion Pump. List Number 11971. 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…
Manufacturer: Hospira Inc.
Category: Medical Device — Infusion Pump
Hazard: therapy-interruption
device-malfunction
Affected units: 357,778

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

List Number 11971. Serial numbers: 13120009
13120017
13120018
13120019
13120026
13120028
13120037
13120041
13120042
13120044
13120057
13120058
13120068
13120071
13120074
13120075
13120082
13120096
13120103
13120104

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · Hospira Inc.

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Same hazard · therapy interruption