The Recall Desk
HighFDA (Devices)·Z-2724-2016·Announced 2016-09-14

Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

Hospira is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and delay or 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 involves a medical device defect that may result in the delay or interruption of therapy, which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Hospira Inc. is recalling 357,778 units of the Plum A+ Infusion Pump, List Number 11973. These devices are self-contained, microprocessor-based infusion systems used for the precise delivery of multiple therapies across the general spectrum of clinical care.

The recall is due to a defect where the fluid shield diaphragm is undersized. This issue may result in alarms and the delay or interruption of therapy. The affected pumps 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.

Healthcare facilities and consumers should identify affected units by checking the serial numbers listed in the official recall notice. Users should stop using the affected pumps and contact Hospira Inc. for instructions on replacement or repair.

The recalled product

Product
Plum A+ Infusion Pump. List Number 11973. 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, microprocessor ba
Manufacturer
Hospira Inc.
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 11973. Serial numbers: 12570148
  • 12570150
  • 12570154
  • 12570163
  • 12570170
  • 12570177
  • 12570204
  • 12570211
  • 12570212
  • 12570255
  • 12570270
  • 12570319
  • 12570359
  • 12570385
  • 12570413
  • 12570425
  • 12570455
  • 12570487
  • 12570662
  • 12570695

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 →