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.

Read the Full FDA Alert