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Infusion Pump Battery Recall: ICU Medical Removes Some CSB Batteries Intended For Use With Plum 360, A+, and A+3 Infusion Systems Due to Reports of Allegedly Counterfeit, Untested Batteries In Use

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product and Allegedly Counterfeit Product

  • Product Names: Batteries for use in Plum 360, Plum A+, and Plum A+3 Infusion Systems
  • All batteries that have:
    • Missing information including no ICU Medlcal Test Label or CE Mark
    • A Date code (yellow label found on side of battery): W2401xxxx - W2406xxx

What to Do  

  • Do not use batteries that do not have an ICU Medical Test Label or CE Mark on the label.
  • Make sure batteries currently used in Plum 360, Plum A+, and Plum A+3 Infusion Systems are not part of this recall.
  • Make sure any entity providing service or repair activities for Plum Infusion Systems uses only parts authorized or directly provided by ICU Medical.

On October 22, 2024, ICU Medical sent all affected customers an Urgent Medical Device Safety Alert recommending the following actions:

For Customers

  • Do not return or stop using Plum 360, Plum A+, or Plum A+3 Infusion Pumps.
  • Identify if you have the allegedly counterfeit batteries by checking the battery labeling. 
  • Remove any of the allegedly counterfeit batteries from use and inventory. Destroy them per organization guidelines.

For Biomedical Engineering

  • Make sure all users or potential users of these pumps are immediately made aware of this alert.
  • Complete and return the attached Response Form to icumedical7561@sedgwick.com within 10 days of receiving it to acknowledge your understanding of the alert.
  • Distributors should forward the alert to any customers who may have received potentially affected products. Request that they complete the response form and return it to icumedical7561@sedgwick.com.

Reason for Recall

ICU Medical is recalling some CSB batteries that are intended for use with Plum 360, Plum A+, and Plum A+3 Infusion Systems after receiving reports of allegedly counterfeit batteries being used with infusion pumps. These batteries have not been tested or validated for use with the systems. Preliminary reports suggest that the batteries fail to hold charge and the pump may display battery replacement messages earlier than expected. 

The use of affected products may cause serious injury or death to patients due to interruption, under-infusion, or delays in the delivery of critical fluids, blood products, and medications.

There have been no reported injuries and no reports of death. 

Device Use

Plum 360, Plum A+, and Plum A+3 Infusion Systems are large volume infusion pumps used to give fluids to patients in precisely controlled infusion amounts and rates. The system delivers blood or blood products, drugs, and other fluid mixtures through subcutaneous, intramuscular, intravenous, and intrathecal administration.

The batteries and replacement batteries for these infusion systems are used when the pump is not plugged into AC power, for example when a patient is being transported.

Contact Information  

Customers in the U.S. should report adverse events or product complaints to Global Complaint Management: 1-844-654-7780 or ProductComplaintsPP@icumed.com. For additional information or other assistance, contact Technical Assistance, 1-800-241-4002, option 3.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 

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