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Lower risk Medical device recall · FDA · Published March 22, 2023

ICU Medical Plum 360 Infusion System Battery Recall: Early Capacity Loss Risk

ICU Medical recalls Plum 360 Infusion System batteries with list number SUB0000864 that may lose capacity earlier than expected. Affected units have CSB BATTERY with first two characters 22 or lower.

🇺🇸 FDA recall #Z-1565-2023Medical deviceICU Medical ›
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Recalling firmICU Medical Inc600 N Field Dr · Lake Forest, IL 60045-4835
✎ GovInfoNow plain-language explainer

ICU Medical is recalling certain Plum 360 Infusion System batteries that may lose capacity earlier than expected. This could lead to shorter battery life than normal, potentially affecting medical device operation. Read more at govinfonow.com/recall/58671-icu-medical-plum-360-infusion-system-battery-recall-early-capacity.

Source Summary by GovInfoNow · govinfonow.com/recall/58671-icu-medical-plum-360-infusion-system-battery-recall-early-capacity · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1565-2023

Cite this page

“ICU Medical Plum 360 Infusion System Battery Recall: Early Capacity Loss Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58671-icu-medical-plum-360-infusion-system-battery-recall-early-capacity. Based on FDA recall #Z-1565-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1565-2023%22&limit=1).

ICU Medical, Inc. recalled Replacement Battery List Number SUB0000864 for the Plum 360 Infusion System on March 22, 2023, according to the FDA. The batteries may lose capacity earlier than expected due to a manufacturing defect.

How to tell if you have it

  • Brand: ICU Medical
  • Product: Replacement Battery List Number SUB0000864 found in Plum 360 Infusion System
  • List Number: 30010
  • Battery identifier: CSB BATTERY with first two characters as 22 or lower
  • Units affected: 28,656

The hazard

Affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected. Overall battery runtime may decrease earlier in the battery lifecycle than expected due to a manufacturing defect from the battery supplier.

Context

GovInfoNow's records show ICU Medical, Inc. has had 60 other recalls on record since June 15, 2017. Other recent recalls include the ICU Medical CADD Yellow Medication Cassette Reservoir Recall (August 20, 2026), the ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), and a recall for product 60004087 (June 10, 2026). Other recent recalls of similar products include the HeartMate 11V Backup Battery Recall (May 13, 2026), the Fresenius Kabi Ivenix Infusion System Software Recall (May 6, 2026), and the Philips Allura Xper FD10C Medical System Recall (December 15, 2025).

How to tell if you have this one

Check for the battery label showing 'CSB BATTERY' with the first two characters as 22 or lower. Affected units are identified by list number SUB0000864 in the Plum 360 Infusion System.

  • Brand
    ICU Medical
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    worldwide
Recall numberProduct, codes & lotsQuantity
Z-1565-2023Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010; All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower28656 units
Z-1566-2023Replacement 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; All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower23815 units
Z-1567-2023ASM Replacement Battery, Component Number SUB0000864; Lot Numbers: 6036488, 6827738, 6827739, 6827740, 8408750, 8408755, 84087579984 units
Z-1568-2023ASM Replacement Battery, Component Number SUB0000594; Lot Numbers: 5660479344 units
Based on the official FDA remedy

What to do — step by step

  1. Check Battery Label

    Look for the battery label showing 'CSB BATTERY' with the first two characters as 22 or lower.

How this recall unfolded

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Mar 22, 202312. FDA classified it Class I: May 16, 202323. Published in FDA’s Enforcement Report: May 24, 202332023
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1565-2023 (March 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1565-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA