Agency classClass IIOur severity:High FDA (Devices)·Z-0208-2014·Announced 2013-11-20

Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Drift

Hospira is recalling 7,691 Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false alarms or undetected occlusions.

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, and the hazard involves a medical device defect that could lead to undetected occlusions or false alarms, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Hospira Inc. is recalling 7,691 units of the Plum A+ Infusion Pump (List Number 12618) due to reports of distal pressure sensor calibration drift. The affected devices are a multipurpose family of infusion systems used for precise delivery of multiple therapies across the general spectrum of clinical care.

The calibration drift may result in the display of specific error codes during setup or infusion, including E180/N180, E181/N181, E186/N186, E187/N187, or E346. Additionally, users may experience false distal occlusion alarms or distal occlusions that may not be properly detected if the sensor calibration has drifted.

The recall covers units distributed worldwide, including the United States (nationwide), Puerto Rico, U.S. Virgin Islands, Croatia, the Dominican Republic, and Turks and Caicos. The specific serial numbers affected are listed in the official recall documentation. Healthcare facilities and users should check their device serial numbers against the provided list and contact Hospira for further instructions.

The recalled product

Product: Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Manufacturer: Hospira Inc.
Category: Medical Device — Infusion Pump
Hazard: calibration-drift
false-alarm
occlusion-detection-failure

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 No. 12618
Serial Numbers: 14040001
14040002
14040003
14040004
14040005
14040006
14040008
14040009
14040010
14040011
14040012
14040014
14040015
14040016
14040017
14040018
14040019
14040020
14040021

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

Same manufacturer · Hospira Inc.

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Same hazard · calibration drift