The Recall Desk
HighFDA (Devices)·Z-0284-2014·Announced 2013-11-20

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

Hospira is recalling 10,669 Plum A+ Infusion Systems because the distal pressure sensor pin may break. This defect can prevent the device from detecting occlusions in the administration set.

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 failure that could lead to undetected occlusions during infusion therapy. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High.

Plain-English summary

Hospira Inc. is recalling 10,669 units of the Plum A+ Infusion System. This cassette-based multifunction infusion system is designed to deliver parenteral, enteral, or epidural infusions and is indicated for use in various therapies, including the administration of whole blood and blood products.

The recall is due to a potential defect where the distal (occlusion) pressure sensor pin may 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 pin can only be detected through visual inspection of the distal pressure 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. The recall number is Z-0284-2014. Users should check their devices for the specific serial numbers listed in the official recall notice and contact Hospira for instructions on how to proceed.

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
Affected units
10,669

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 11971
  • Serial Numbers: 13120009
  • 13120017
  • 13120018
  • 13120019
  • 13120026
  • 13120028
  • 13120037
  • 13120041
  • 13120042
  • 13120044
  • 13120057
  • 13120058
  • 13120068
  • 13120071
  • 13120074
  • 13120075
  • 13120082
  • 13120096
  • 13120103

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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