Hospira Recalls Plum A+3 Infusion Pumps Due to Door Roller Defect
Hospira is recalling 28,599 Plum A+3 infusion pumps worldwide because a door roller assembly may break, potentially causing unrestricted flow or over-delivery of IV medication.
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 risk of harm (unrestricted flow/over-delivery) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Hospira Inc. is recalling 28,599 units of the Plum A+3 Triple Channel Infusion Pump. The affected devices were distributed worldwide, including in the United States, Puerto Rico, and numerous international markets. The recall covers specific software configurations identified by list numbers 12348, 12618, and 20678.
The recall was initiated because the door roller assembly on the infuser has the potential to break. If this component fails, 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 Plum A+3 is a volumetric infusion system used for precise delivery of multiple i.v. therapies in various clinical settings, including ICUs, operating rooms, and home care.
Healthcare facilities and users should stop using the affected infusion pumps immediately. They should contact Hospira Inc. for further instructions on how to return or replace the devices. No specific instructions for individual consumers are provided in the source text, as these are professional medical devices.
The recalled product
- Product
- Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum…
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 28,599
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 (4)
- list numbers 12348
- 12618
- and 20678
- 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.
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