Agency classClass IIOur severity:Severe FDA (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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: over-delivery
unrestricted-flow
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 →

Same manufacturer · Hospira Inc.

See all →

Critical
Hospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
Moderate
Hospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
Low
Hospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
Severe
Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
High
Hospira Symbiq Infusion Pump Recalled for White Screen Shutdown
FDA (Devices) · 2016-11-16

Same hazard · over delivery