The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1833-2016·Announced 2016-06-15

Hospira Recalls 2,567 Plum A+ Infusion Pumps Due to Calibration Error

Hospira is recalling 2,567 Plum A+ infusion pumps because a calibration error caused false occlusion alarms. The devices were distributed in the U.S. and 13 foreign countries.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 malfunction (false alarms) that poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Hospira Inc. is recalling 2,567 Plum A+ dual-line volumetric infusion pumps. The recall was initiated after the firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out-of-specification metal cassette. This process resulted in an offset in proximal pressure.

The affected devices are identified by specific list numbers, including 12391-04-25, 12391-22-05, and 20792-88-69. The Plum A+ system is designed for hospital-wide, alternate site, and home healthcare standardization, featuring primary and secondary line delivery capabilities.

The recall covers units distributed nationwide in the United States as well as in Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, the United Kingdom, and Uruguay. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these devices.

The recalled product

Product
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for…
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pumps
Hazard
Affected units
2,567

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 (16)

  • PLum A+ devices with the following list numbers: 12391-04-25
  • 12391-22-05
  • 12391-23-05
  • 12391-23-15
  • 12391-36-07
  • 12391-54-05
  • 12391-88-01
  • 12391-88-02
  • 12391-88-03
  • 12391-88-04
  • 12391-88-05
  • 20792-04-25
  • 20792-13-09
  • 20792-57-15
  • 20792-65-01
  • 20792-65-02 and 20792-88-69.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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