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Plum solo and plum duo precision IV pumps

Official notice

14 May 2026

MediumHealth Canada

An official Health Canada notice concerns Plum solo and plum duo precision IV pumps. Internal testing revealed that under certain conditions, the pump may not display a soft limit alert. LifeShield infusion safety software provides the option to define the maximum dose for the infusion, enable bolus delivery, and define hard and soft limits for the bolus. If the clinician programs a bolus delivery with a medication ruleset that has a maximum dose and bolus soft limits (either lower or upper) defined, and the programmed bolus violates a soft limit, the pump does not notify the clinician of the soft limit violation before confirming and starting delivery. In this scenario, the pump allows the clinician to confirm and start the bolus without displaying the bolus soft limit alert pop-up, and the dose soft limit icon does not appear on the confirmation screen. The pump does display the soft limit icon on the delivery screen once the bolus starts. Hard limits continue to function as expected. Published 2026-05-14.

What to do now

Please contact ICU Medical, device correction inquires, regaring this action: https://icumed.custhelp.com/app/marketaction

Recall number

82074

Official notice

2026-05-14

The hazard

Internal testing revealed that under certain conditions, the pump may not display a soft limit alert. LifeShield infusion safety software provides the option to define the maximum dose for the infusion, enable bolus delivery, and define hard and soft limits for the bolus. If the clinician programs a bolus delivery with a medication ruleset that has a maximum dose and bolus soft limits (either lower or upper) defined, and the programmed bolus violates a soft limit, the pump does not notify the clinician of the soft limit violation before confirming and starting delivery. In this scenario, the pump allows the clinician to confirm and start the bolus without displaying the bolus soft limit alert pop-up, and the dose soft limit icon does not appear on the confirmation screen. The pump does display the soft limit icon on the delivery screen once the bolus starts. Hard limits continue to function as expected.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

40001-04-01, 40002-04-03

Other

RA RA-82074

Model Numbers

40001-04-01, 40002-04-03

Recall Numbers

82074

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Affected products

Product 1

Lot or serial number - Logiciel: V1.0.3, Model or catalogue number - 40001-04-01

Product 2

Lot or serial number - Logiciel: V1.2.3, Model or catalogue number - 40002-04-03

Risk / hazard

Internal testing revealed that under certain conditions, the pump may not display a soft limit alert. LifeShield infusion safety software provides the option to define the maximum dose for the infusion, enable bolus delivery, and define hard and soft limits for the bolus. If the clinician programs a bolus delivery with a medication ruleset that has a maximum dose and bolus soft limits (either lower or upper) defined, and the programmed bolus violates a soft limit, the pump does not notify the clinician of the soft limit violation before confirming and starting delivery. In this scenario, the pump allows the clinician to confirm and start the bolus without displaying the bolus soft limit alert pop-up, and the dose soft limit icon does not appear on the confirmation screen. The pump does display the soft limit icon on the delivery screen once the bolus starts. Hard limits continue to function as expected.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Icu Medical.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

82074

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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