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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

ICU Medical Inc: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

Agency Publication Date: May 16, 2023
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Affected Products

Product: Replacement 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 lower

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

All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower

Product: ASM Replacement Battery, Component Number SUB0000864

Lot Numbers: 6036488, 6827738, 6827739, 6827740, 8408750, 8408755, 8408757

Lot Numbers:
Numbers
Product: ASM Replacement Battery, Component Number SUB0000594

Lot Numbers: 5660479

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91874
Status: Active
Manufacturer: ICU Medical Inc
Manufactured In: United States
Units Affected: 4 products (28656 units; 23815 units; 9984 units; 344 units)
Agency Last Updated: May 23, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.