Agency classClass IOur severity:Severe FDA (Devices)·Z-1074-2015·Announced 2015-03-04

Hospira Recalls Plum A+ Infusion Pumps With Silent Alarm Defect

Hospira is recalling nine Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels."

Plain-English summary

Hospira Inc. is recalling nine units of the Plum A+ Infusion System. The recall involves one lot of alarm assemblies used in these pumps, which may fail to sound at all volume levels.

The affected devices are cassette-based multi-function infusion systems designed for standard, piggyback, or concurrent delivery of parenteral, enteral, or epidural infusions. The specific units involved have serial numbers 18807410, 18807428, 18807439, 18807459, 18807511, 18807523, 18807578, 16792228, and 16792250.

These devices were distributed worldwide, including in the United States, Puerto Rico, and numerous international locations such as Canada, Brazil, and the United Kingdom. Healthcare facilities should check their inventory for these specific serial numbers and contact Hospira for instructions on how to proceed.

The recalled product

Product: The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or…
Manufacturer: Hospira Inc.
Category: Medical Device — Infusion Pumps
Hazard: alarm-failure
Affected units: 9

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 (9)

1) List Number:11005: Serial Numbers: 18807410
18807428
18807439
18807459
18807511
18807523
18807578
16792228
16792250

Distribution

Distributed in 50 states:

Part of a larger recall action

This product is one of 5 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 5 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 Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16

Same hazard · alarm failure