The Recall Desk
HighFDA (Devices)·Z-0290-2014·Announced 2013-11-20

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

Hospira Inc. is recalling Plum A+ Infusion Systems because the distal 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 is classified as FDA Class II, and the hazard involves a medical device that may fail to detect occlusions, posing a risk of harm to patients, although no injuries are reported in the source text.

Plain-English summary

Hospira Inc. is recalling the Plum A+ Infusion System, a cassette-based multifunction infusion device used for parenteral, enteral, and epidural therapies. The recall is due to a potential defect where the distal (occlusion) pressure sensor pin may break. This pin is a critical component 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.

The affected units are distributed worldwide, including the United States, Puerto Rico, U.S. Virgin Islands, Costa Rica, and the Dominican Republic. The recall covers specific serial numbers listed under List Number 20679 and List Number 20792. A broken distal pin can only be detected through a visual inspection of the distal pressure pin.

Healthcare facilities and users should stop using the affected infusion systems and contact Hospira Inc. for further instructions on the recall process. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
The Plum A+ 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+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions o
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)

  • *** 1) List Number 20679
  • Serial Numbers: 15441019
  • 15441020
  • 15441037
  • 15441044
  • 15441082
  • 15441093
  • 15441118
  • 15441226
  • 15441229
  • 15441230
  • 15441240
  • 15441241
  • 15441244
  • 15441246
  • 15441247
  • 15441249
  • 15441253
  • 15441256
  • 15441258

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 →

Related recalls

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Same hazard · device failure

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