Agency classClass IIOur severity:High FDA (Devices)·Z-0206-2014·Announced 2013-11-20

Hospira Recalls Plum A+3 Infusion Pumps Due to Pressure Sensor Drift

Hospira is recalling 214 Plum A+3 Infusion Pump Systems because distal pressure sensor calibration drift may cause false alarms or 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 malfunction (pressure sensor drift) that poses a risk of harm to patients through false alarms or occlusions, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Hospira Inc. is recalling 214 units of the Plum A+3 Infusion Pump System (List Number 12348) due to reports of distal pressure sensor calibration drift. The affected devices are a multipurpose family of infusion systems used for precise delivery of therapies in 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 actual distal occlusions that may not be properly managed due to the sensor issue.

The affected units were distributed nationwide in the United States, including Puerto Rico and the U.S. Virgin Islands, as well as in Croatia, the Dominican Republic, and Turks and Caicos. Users should check their device serial numbers against the provided list and contact Hospira for further instructions on corrective actions.

The recalled product

Product: Plum A+3 Infusion Pump System; List Number: 12348; 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: sensor-drift
false-alarm
occlusion

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. 12348
Serial Numbers: 13740156
13740256
13740266
13740351
13740380
13740451
13740508
13740612
13740632
13740731
13740732
13740733
13740734
13740735
13740736
13740737
13740738
13740739
13740740

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 · sensor drift