ICU Medical, Inc. recalls Plum Duo Infusion System
Reason for recall
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Plum Duo Infusion System, List Number: 400020401
Lot / code information
- UDI
- M335400021
- Serial #
50000124 50004386 50006225 50000300 50003767 50006228 50004719 50005562 50001512 50002063 50002087 50000125 50004387 50006224 50001628 50003768 50006227 50004720 50005566 50001513 50002064 50002091 50…Show all
50000124 50004386 50006225 50000300 50003767 50006228 50004719 50005562 50001512 50002063 50002087 50000125 50004387 50006224 50001628 50003768 50006227 50004720 50005566 50001513 50002064 50002091 50000126 50004389 50006223 50001785 50003775 50006218 50004722 50005572 50001514 50002065 50002107 50000127 50004390 50006220 50002461 50003776 50006205 50004725 50005619 50001515 50002066 50002114 50000128 50004391 50006217 50002491 50003785 50006198 50004726 50005639 50001516 50002067 50002120 50000129 50004392 50006215 50002541 50003786 50006197 50004727 50005663 50001517 50002068 50002123 50000130 50004393 50006214 50002598 50003787 50006183 50004729 50005669 50001518 50002069 50002126 50000131 50004394 50006213 50002599 50003789 50006163 50004730 50005678 50001519 50002070 50002128 50000132 50004395 50006212 50002603 50003793 50006151 50004731 50005680 50001520 50002072 50002143 50000133 50004396 50006211 50002620 50003794 50006150 50004732 50005710 50001521 50002073 50002144 50000134 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500047 …
Additional code information
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What the firm is doing
An "URGENT: MEDICAL DEVICE CORRECTION" notification letter dated 7/11/25 was sent to customers. The letter described the product, problem and actions to be taken. Actions for Users: 1. Identify all affected infusion pumps in your possession and ensure all users or potential users of these pumps are immediately made aware of this notification. 2. 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. 3. If the pump becomes unresponsive, exchange the pump and reprogram. Follow-up Actions by ICU Medical: ICU Medical will develop a patch to correct this issue for Plum Duo. ICU Medical will contact you to schedule the software update for your pumps if needed. https://icumed.custhelp.com/app/market-action For any questions regarding this action Technical Support 1-(800)-241-4002, option 3 tsc.support@icumed.com
DistributionShow detailsHide
US Nationwide.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2129-2025
- FDA 510(k) clearance · K223607The device's official FDA premarket clearance record
- FDA device classification · FRNOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5725The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find ICU Medical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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