The Recall Desk
SevereFDA (Devices)·Z-1075-2015·Announced 2015-03-04

Hospira Recalls Plum A+ Infusion Pumps Due to Alarm Failure

Hospira is recalling 190 Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class I recall, which mandates a severity score of at least 4 according to the rubric, due to the potential for serious injury or death from alarm failure.

Plain-English summary

Hospira Inc. is recalling 190 units of the Plum A+ Infusion System. The recall involves one lot of alarm assemblies used in these pumps, which may fail to sound at all volume levels.

The affected devices are distributed worldwide, including in the United States, Puerto Rico, and various international locations. The recall is based on the potential for the alarm system to malfunction, which could prevent the device from alerting users to critical infusion status changes.

Healthcare facilities and users should check their serial numbers against the list provided by the FDA to determine if their devices are affected. If a device is included in the recall, users should follow the instructions provided by Hospira for repair or replacement.

The recalled product

Product
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or c
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
190

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: 14040926
  • 14041563
  • 14041565
  • 14041611
  • 14041627
  • 14041901
  • 14041912
  • 14041921
  • 14041953
  • 14041960
  • 14041964
  • 14041973
  • 14040654
  • 14041065
  • 14041554
  • 14041604
  • 14041606
  • 14041621
  • 14041902
  • 14042270

Distribution

Distributed in 50 states:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Related recalls

Same manufacturer · Hospira Inc.

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Same hazard · alarm failure

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