ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump

Summary

The FDA issued a Class II for ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) It by ICU Medical, Inc.. Reason: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the V.

Details

Product Description

ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump

Lot/Code Info: 1) UDI/DI +M335400021, Serial Numbers: 50003704, 50003710, 50004046, 50004072, 50004149, 50004154, 50004156, 50004163, 50004166, 50004168, 50004177, 50004183, 50004205, 50004218, 50004220, 50004249, 50004258, 50004262, 50004263, 50004264, 50004271, 50004300, 50004303, 50004304, 50004305, 50004307, 50004308, 50004310, 50004312, 50004314, 50004316, 50004318, 50004319, 50004323, 50004324, 50004325, 50004326, 50004328, 50004330, 50004331, 50004332, 50004333, 50004334, 50004335, 50004336, 50004338, 50004339, 50004340, 50004341, 50004342, 50004344, 50004345, 50004346, 50004347, 50004348, 50004349, 50004350, 50004351, 50004352, 50004356, 50004358, 50004359, 50004361, 50004363, 50004365, 50004366, 50004370, 50004372, 50004373, 50004374, 50004376, 50004380, 50004382, 50004383, 50004384, 50004385, 50004386, 50004387, 50004389, 50004390, 50004391, 50004392, 50004393, 50004394, 50004395, 50004396, 50004398, 50004399, 50004401, 50004403, 50004405, 50004407, 50004409, 50004410, 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Quantity Affected: 12525 units

Reason for Recall

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-06-10

Company