CLASS II Device recall · Reported 19 Jul 2017 · FDA Enforcement Report

The Plum A+ Infusion Systems are a multipurpose family recalled by ICU

ICU is recalling The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise, distributed nationwide in the US. The recall was initiated on 1 Feb 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList number: 11973 Serial Numbers 12570148 12570150 12570154 12570163 12570170 12570177 12570204 12570211 12570212 12570255 12570270 12570319 12570359 12570385 12570413 12570425 12570455 12570487 12570662 12570695 12570854 12570915 12571080 12571243 12571437 12571631 12571692 12571776 12571826 12571835 12571837 12571842 12571877 12571880 12571886 12572317 12572369 12572586 12572909 12573547 12573567 12573837 12573990 12574424 12574501 12574524 12574556 12574599 12574619 12574731 12574749 12574853 12574858 12574860 12574865 12574961 12575626 12575698 12575886 12576125 12576443 12576485 12576518 12576593 12576609 12576710 12576722 12577271 12577685 12578856 12579183

Quantity recalled71 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2677-2017
FDA event ID: 64542
Recalling firm: ICU, Lake Forest, IL
Classification: Class II
Status: Terminated
Recall initiated: 1 Feb 2013
FDA classified: 10 Jul 2017
Reported: 19 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

1 Feb 2013	Recall initiated by company
10 Jul 2017	Classified by FDA	+1620 days
19 Jul 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

The Plum A+ Infusion Systems are a multipurpose 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, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

Where it was distributed

Nationwide, Worldwide

Nationwide

Questions about this recall

Is The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise recalled?

Yes. ICU recalled The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise on 1 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-2677-2017.

Why was it recalled?

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

Which lots are affected?

List number: 11973 Serial Numbers 12570148 12570150 12570154 12570163 12570170 12570177 12570204 12570211 12570212 12570255 12570270 12570319 12570359 12570385 12570413 12570425 12570455 12570487 12570662 12570695 12570854 12570915 12571080 12571243 12571437 12571631 12571692 12571776 12571826 12571835 12571837 12571842 12571877 12571880 12571886 12572317 12572369 12572586 12572909 12573547 12573567 12573837 12573990 12574424 12574501 12574524 12574556 12574599 12574619 12574731 12574749 12574853 12574858 12574860 12574865 12574961 12575626 12575698 12575886 12576125 12576443 12576485 12576518 12576593 12576609 12576710 12576722 12577271 12577685 12578856 12579183

Where was it sold?

Nationwide, Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from ICU

All 2

Reported	Class	Recall	Company	Reason	Where
19 Jul 2017Device	CLASS II	The Plum A+ Infusion Systems are a multipurpose family recalled by ICU	ICU	Device Malfunction	Nationwide

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19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	Nationwide