FDA Device recall Z-2129-2025
Plum Duo Infusion System, List Number: 400020401
- FDA Device
- Class I
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class I recall of Plum Duo Infusion System, List Number: 400020401 by Icu Medical, citing ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2129-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-07-11 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
Plum Duo Infusion System, List Number: 400020401
Reason
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Identifiers
| code_info | UDI-DI: M335400021; Serial Numbers: 50000124 50004386 50006225 50000300 50003767 50006228 50004719 50005562 50001512 50…UDI-DI: M335400021; Serial Numbers: 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 5 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2129-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.