The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0481-2013·Announced 2012-12-19

Hospira Recalls Plum A+ Infusion Pumps Due to Reversed Volume Knob

Hospira is recalling Plum A+ single channel infusion pumps because the volume control knob may function in reverse, causing alarm volume to increase when turned clockwise.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard involves a functional discrepancy in the volume control knob rather than a direct risk of serious injury or death, fitting the criteria for moderate severity.

Plain-English summary

Hospira, Inc. is recalling certain Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules. The recall involves specific pump and module list numbers, including pump list numbers 11971, 11973, and 12391, and associated module list numbers 12101, 12102, 12393, 12380, 12097, and 12680. The devices were distributed worldwide, including in the United States, Puerto Rico, and numerous international markets.

The recall was initiated because the volume control knob located on the back of the infuser may not function as described in the System Operating Manual. While the manual indicates that a clockwise rotation of the knob decreases the volume, on some of the affected devices, the alarm volume increases when the knob is turned clockwise. This discrepancy may result in unintended alarm volume levels during clinical use.

Healthcare facilities and users of these infusion pumps should contact Hospira for further instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.

The recalled product

Product
Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number…
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pump
Hazard

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 (8)

  • pump list number 11971
  • module list numbers 12101
  • 12102 and 12393
  • pump list number 11973
  • module list number 12380
  • pump list number 12391
  • module list numbers 12097 and 12680
  • all serial numbers

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 3 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 3 products in this recall →

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