The Recall Desk
HighFDA (Devices)·Z-0288-2014·Announced 2013-11-20

Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk

Hospira is recalling 7,692 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line 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 involves a medical device defect that could prevent the detection of line occlusions, posing 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 7,692 units of the Plum A+3 Infusion System. This cassette-based multifunction infusion system is designed to deliver parenteral, enteral, or epidural infusions and is used in standard, piggyback, or concurrent delivery modes.

The recall is due to a defect where the distal (occlusion) pressure sensor pin has the potential to break. This pin is part of the subsystem that measures pressure within the distal line of the administration set to indicate the presence of a full or partial distal occlusion. A broken distal pin can only be detected through visual inspection of the pin.

The affected units were distributed nationwide in the United States, including all states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, as well as in Costa Rica and the Dominican Republic. Healthcare facilities should inspect the distal pressure pins on these devices for breakage.

The recalled product

Product
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
7,692

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)

  • 1) List Number 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 52 states specifically:

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

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