Agency classClass IOur severity:Severe FDA (Devices)·Z-2448-2024·Announced 2024-08-21

Plum A+ and Plum A+3 Infusion Pump Batteries Recalled for Capacity Loss Defect

ICU Medical is recalling Plum A+ and Plum A+3 infusion pump batteries due to a manufacturing defect that may cause premature capacity loss and reduced runtime. Approximately 14,744 units were distributed worldwide.

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: This is an FDA Class I device recall. Battery capacity loss in infusion pumps could interrupt essential medication delivery, though no illnesses or injuries are reported. FDA Class I classification requires a minimum Severe rating per the rubric.

Plain-English summary

ICU Medical Inc is recalling replacement batteries for Plum A+ and Plum A+3 infusion systems. The affected batteries are List Numbers SUB0000594 and SUB0000864. Approximately 14,744 units were distributed worldwide, including to the United States and 17 other countries.

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected. As a result, overall battery runtime may decrease earlier than expected.

This recall affects all users of Plum A+ and A+3 infusion systems with the affected battery list numbers. Consumers and healthcare facilities should verify their equipment serial numbers against the FDA recall information to determine if they have affected devices.

The recalled product

Product: Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New…
Manufacturer: ICU Medical Inc
Category: Medical Device — Infusion pump batteries
Hazard: battery-capacity-loss
power-loss
device-malfunction
Affected units: 14,744

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)

1. Product Code: 206782284. No UDI Number (Serial Numbers: 16095234
18077407
18077421
18077507
18077551
18077561
18077621
18077674
18077677
18077701
18077737
18077794
18077797
18077824
18077831
18077897
18077941
18077977
18078084
18078101

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by ICU Medical 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 3 products in this recall →

Same manufacturer · ICU Medical Inc

See all →

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High
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High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
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Moderate
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FDA (Devices) · 2026-09-23

Same hazard · battery capacity loss