Agency classClass IIOur severity:High FDA (Devices)·Z-2726-2016·Announced 2016-09-14

Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.

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. The hazard involves the delay or interruption of therapy, which poses a risk of harm to patients, but the source text does not report any specific injuries or fatalities.

Plain-English summary

Hospira Inc. is recalling 357,778 units of the Plum A+ Infusion Pump with Hospira MedNet Software (List Number 20679). The recall is due to a defect where the fluid shield diaphragm is undersized.

This defect may result in alarms and the delay or interruption of therapy. The affected devices were distributed nationwide in the United States, including Puerto Rico and the U.S. Virgin Islands, as well as in Costa Rica, Turks and Caicos, and the Dominican Republic.

Healthcare facilities and users should check their inventory for the specific serial numbers listed in the official recall notice. If a device is affected, it should be removed from service and returned to Hospira Inc. for evaluation or replacement.

The recalled product

Product: Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are…
Manufacturer: Hospira Inc.
Category: Medical Device — Infusion Pump
Hazard: therapy-interruption
device-malfunction
Affected units: 357,778

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 (20)

List Number 20679. Serial numbers: 15441019
15441020
15441037
15441044
15441082
15441093
15441118
15441226
15441229
15441230
15441240
15441241
15441244
15441246
15441247
15441249
15441253
15441256
15441258
15441260

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 9 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 9 products in this recall →

Same manufacturer · Hospira Inc.

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Same hazard · therapy interruption