Agency classClass IOur severity:Severe FDA (Devices)·Z-1566-2023·Announced 2023-05-24

Plum A+ & A+3 Infusion System Batteries Recalled Due to Manufacturing Defect

ICU Medical Inc is recalling replacement batteries used in Plum A+ and A+3 infusion pump systems. A manufacturing defect may cause batteries to lose capacity earlier than expected.

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 recall is classified as FDA Class I, which requires immediate notification and indicates the defect could directly impact device performance and patient safety. No illnesses or injuries have been reported in the source text, but the FDA's Class I designation reflects the serious potential for harm from premature battery failure in an infusion system.

Plain-English summary

ICU Medical Inc is recalling replacement batteries (CSB BATTERY, List Number SUB0000594) used in Plum A+ and Plum A+3 infusion pump systems. The recall affects 23,815 units distributed worldwide.

Due to a manufacturing defect from the battery supplier, affected batteries may experience loss of capacity earlier in the battery lifecycle than expected. This results in decreased overall battery runtime earlier than anticipated.

The recall applies to all replacement batteries with serial codes where the first two characters are "22" or lower.

The recalled product

Product: Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973
Manufacturer: ICU Medical Inc
Category: Medical Device
Hazard: battery-failure
device-malfunction
Affected units: 23,815

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · ICU Medical Inc

See all →

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

Same hazard · battery failure