The Recall Desk
HighFDA (Devices)·Z-0209-2014·Announced 2013-11-20

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

Hospira is recalling Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false occlusion alarms or missed occlusions.

What this means for you

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 defect involves a risk-of-harm product (infusion pump) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Hospira Inc. is recalling specific models of the Plum A+ Infusion Pump, including units labeled as PLUM A+3 and PLUM A+ for use with Hospira MedNet. The recall covers three list numbers: 20678, 20679, and 20792. The total quantity of affected units is 155,984, comprising 21,551 units from list 20678, 7,737 units from list 20679, and 126,696 units from list 20792.

The recall was initiated due to reports of distal pressure sensor calibration drift. This defect 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, the calibration drift may cause users to experience false distal occlusion alarms or fail to detect actual distal occlusions.

The affected devices were distributed worldwide, including nationwide in the United States and in the countries of Croatia, the Dominican Republic, and Turks and Caicos. The source text does not specify the corrective action consumers or healthcare facilities should take, nor does it report any illnesses or injuries associated with the defect.

The recalled product

Product
*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with Hospira MedNet
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pump
Hazard

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 →

Related recalls

Same manufacturer · Hospira Inc.

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Same hazard · calibration drift

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