Agency classClass IIOur severity:High FDA (Devices)·Z-2722-2016·Announced 2016-09-14

Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

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

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 involves a risk of harm (delay or interruption of therapy) without reported injuries or fatalities, meeting the criteria for a High severity score.

Plain-English summary

Hospira Inc. is recalling 357,778 units of the Plum A+ Hyperbaric Infusion Pump, List Number 11005. The recall covers devices 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.

The recall was initiated because the fluid shield diaphragm for these infusion pumps was undersized. This defect may result in alarms or the delay or interruption of therapy. The agency has classified this as a Class II recall.

Healthcare facilities and users should check their inventory for the specific serial numbers listed in the official recall notice. Affected units should be removed from service and returned to Hospira Inc. for evaluation or replacement.

The recalled product

Product: Plum A+ Hyperbaric Infusion Pump. List Number 11005. 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 self-contained…
Manufacturer: Hospira Inc.
Category: Medical Device — Infusion Pump
Hazard: device-malfunction
therapy-interruption
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 11005. Serial numbers: 16792201
16792202
16792205
16792206
16792208
16792209
16792210
16792211
16792213
16792216
16792217
16792219
16792220
16792222
16792223
16792224
16792225
16792226
16792227
16792228

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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