The Recall Desk
SevereFDA (Devices)·Z-0624-2013·Announced 2013-01-09

Hospira Recalls Plum A+ Infusion Pumps Due to Door Roller Defect

Hospira is recalling 297,833 Plum A+ infusion pumps because a door roller assembly may break, causing unrestricted flow or over-delivery of IV fluids.

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 recall is classified as FDA Class II, and the defect poses a risk of significant injury through over-delivery of IV fluids, meeting the criteria for a Severe rating.

Plain-English summary

Hospira Inc. is recalling 297,833 units of the Plum A+ Single Channel Infusion Pumps. The affected pumps were sold in various configurations, including list numbers 11971, 11973, 12391, 20679, and 20792, and were distributed worldwide, including in the United States, Puerto Rico, and numerous international markets.

The recall is due to a defect in the door roller assembly, which has the potential to break. If the assembly breaks, it can lead to possible unrestricted flow and/or over-delivery of medication during the removal of the IV administration set's cassette from the pump. The FDA has classified this as a Class II recall.

Healthcare facilities and users of these infusion pumps should contact Hospira for further instructions on how to address the defect. The pumps are used for precise delivery of multiple i.v. therapies across various clinical settings, including ICU, OR, and home care.

The recalled product

Product
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792
Manufacturer
Hospira Inc.
Category
Medical Device — Infusion Pumps
Hazard
Affected units
297,833

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 (6)

  • list numbers 11971
  • 11973
  • 12391
  • 20679
  • and 20792
  • all serial numbers

Distribution

Distributed in 1 state:

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 →

Related recalls

Same manufacturer · Hospira Inc.

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Same hazard · over delivery

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