This recall involves correcting certain devices and does not involve removing them 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 without correction.
Affected Product
- Product Names: Plum Duo Infusion System with Software Version 1.1.3 and Earlier
- Unique Device Identifier (UDI): 400020401
- Model: M335400021
What to Do
Identify all devices subject to the correction. Unless taking the devices out of circulation would result in a clinically meaningful pump shortage, devices should be quarantined until a software patch becomes available.
On July 1, 2025, ICU Medical sent all affected customers an Urgent Medical Device Correction recommending the following actions:
- Identify all affected infusion pumps in possession and quarantine affected devices until a patch is available.
- Ensure all users or potential users of these pumps are immediately made aware of this notification.
- ICU Medical will develop a patch to correct this issue for Plum Duo and contact all customers to schedule the software update for pumps as needed.
If removing the pumps from circulation would prove detrimental to patient care, the following risk mitigation strategy should be pursued:
To stop an infusion, ensure that users carefully attend to the "CONFIRM STOP" message that appears after pressing the “STOP” button. The "CONFIRM STOP" message includes a yes/no selection to confirm the intent to stop the infusion, thereby helping to prevent unintended interruptions.
If the pump becomes unresponsive, exchange the pump and reprogram.
Reason for Correction
ICU Medical is correcting the Plum Duo Infusion System due to the pump software possibly resulting in the pump becoming unresponsive. Pumps may experience two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive. This may result in delay of therapy or interruption of therapy.
Use of the affected product may cause serious adverse health consequences, including those related to delay in initiation of therapy, over-delivery, interruption of therapy, or death.
There have been no reported injuries or deaths related to this issue.
Device Use
The Plum Duo Infusion System is intended for parenteral fluids and medications through clinically acceptable routes (limited to intravenous, intra-arterial, and subcutaneous therapies).
The Plum Duo Infusion System is intended for use in hospitals and outpatient healthcare facilities by licensed healthcare professionals. These healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use.
The Plum Duo Infusion System is intended for adult, pediatric (both infants and children), and neonatal patient populations.
Contact Information
Customers in the U.S. with questions about this recall should contact ICU Medical Technical Support at 1-800-241-4002 and select option 3.
Additional FDA Resources:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved 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.
