FDA Medical devices recall ·
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and… recall
- Recall number
- Z-2723-2026
- Date
- (initiated June 10, 2026)
- Company / brand
- ICU Medical, Inc.
600 N Field Dr, Lake Forest, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12525 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, 50004411, 50004413, 50004415, 50004416, 50004417, 50004424, 50004425, 50004426, 50004428, 50004431, 50004433, 50004435, 50004436, 50004438, 50004439, 50004442, 50004443, 50004444, 50004445, 50004448, 50004449, 50004451, 50004452, 50004455, 50004458, 50004460, 50004461, 50004462, 50004464, 50004465, 50004467, 50004468, 50004469, 50004471, 50004472, 50004473, 50004474, 50004477, 50004481, 50004482, 50004486, 50004487, 50004493, 50004495, 50004499, 50004501, 50004502, 50004506, 50004510, 50004512, 50004513, 50004515, 5
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2723-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.