The Recall Desk
HighFDA (Devices)·Z-2728-2016·Announced 2016-09-14

Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

Hospira is recalling 357,778 Plum A+3 Infusion Pump Systems because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.

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 the potential interruption of medical therapy, which poses a risk of harm to patients, though no specific injuries or deaths are reported in the source text.

Plain-English summary

Hospira Inc. is recalling 357,778 units of the Plum A+3 Infusion Pump System (List Number 12348). These devices are self-contained, microprocessor-based infusion pumps used to provide precise delivery of multiple therapies across the general spectrum of clinical care.

The recall is due to a defect where the fluid shield diaphragm for the Plum A+ Infusion pumps was undersized. This defect may result in alarms and the delay or interruption of therapy.

The affected units were distributed nationwide in the United States, including Puerto Rico and the U.S. Virgin Islands, as well as in Costa Rica, Turks and Caicos, and the Dominican Republic. Specific serial numbers are listed in the official recall documentation.

The recalled product

Product
Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microproc
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
357,778

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 number 12348
  • Serial Numbers: 13740156
  • 13740256
  • 13740266
  • 13740351
  • 13740380
  • 13740451
  • 13740508
  • 13740612
  • 13740632
  • 13740731
  • 13740732
  • 13740733
  • 13740734
  • 13740735
  • 13740736
  • 13740737
  • 13740738
  • 13740739
  • 13740740

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

Related recalls

Same manufacturer · Hospira Inc.

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Same hazard · device defect

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