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FDAFDA · Food and drugs·Recall number Z-2448-2024

Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set

Published August 21, 2024 · Recall initiated: May 7, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
ICU Medical Inc
Distributor
Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Australia, Canada, France, Guadeloupe, Guatemala, Ireland, Italy, Oman, Paraguay, Qatar, Spain, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
Lot
1. Product Code: 206782284. No UDI Number (Serial Numbers: 16095234, 18077407, 18077421, 18077507, 18077551, 18077561, 18077621, 18077674, 18077677, 18077701, 18077737, 18077794, 18077797, 18077824, 18077831, 18077897, 18077941, 18077977, 18078084, 18078101, 18078141, 18078147, 18078151). 2. Product Code: 207920425. No UDI Number (Serial Numbers: 17738835, 17738841, 17738890, 17738893, 17738894, 17738897, 17738898, 17738899, 17738900, 17738901, 17738903, 17738906, 17738911, 17738915, 17738916, 17738918, 17738919, 17738920, 17738921, 17738922, 17738923, 17738925, 17738926, 17738928, 17738930, 17738931, 17738932, 17738933, 17738934, 17738935, 17738936, 17738944, 17738949, 17738953, 17739019, 17739119, 17739125, 17739127, 17739128, 17739130, 17739132, 17739135, 17739137, 17739140, 17739143, 17739145, 17739148, 17739151, 17739160, 17739161, 17739163, 17739164, 17739165, 17739166, 17739168, 17739174, 17739176, 17739180, 17739182, 17739184, 17739185, 17739186, 17739187, 17740923, 17743586, 17749108, 17749143, 17749569, 17749760, 17749803, 17749829, 17750043, 17750610, 17750658, 17750715, 17753103, 17753259, 17753640, 17753665, 17753918, 17753934, 17753935, 17754024, 17754042, 17754098, 17754276, 17754307, 17754387, 17754499, 17754525, 17754531, 17754565, 17754568, 17754577, 17754631, 17754780, 17754838, 17754882, 17755139, 17755145, 17756153, 17756171, 17756203, 17756242, 17756312, 17756315, 17756322, 17756323, 17756325, 17756326, 17756327, 17756328, 17756329, 17756332, 17756333, 17756334, 17756335, 17756338, 17756340, 17756344, 17756345, 17756347, 17756348, 17756349, 17756356, 17756363, 17756364, 17756365, 17756371, 17756379, 17756382, 17756394, 17756402, 17756405, 17756406, 17756408, 17756410, 17756411, 17756412, 17756413, 17756417, 17756418, 17756420, 17756421, 17756424, 17756425, 17756430, 17756453, 17756457, 17756472, 17756477, 17756484, 17756487, 17756488, 17756497, 17756502, 17756506, 17756509, 17756516, 17756517, 17756518, 17756519, 17756520, 17756521, 17756525, 17756527, 17756529, 17756532, 17756563, 17756577, 17756587, 17756619, 17756623, 17756627, 17756628, 17756638, 17756639, 17756641, 17756651, 17756660, 17756683, 17756695, 17756709, 17756726, 17756785, 17756788, 17756816, 17756830, 17756845, 17756857, 17756956, 17757007, 17757056, 17757069, 17757126, 17757173, 17757176, 17757187, 17757203, 17757207, 17757229, 17757230, 17757233, 17757236, 17757238, 17757244, 17757249, 17757256, 17757266, 17757274, 17757291, 17757292, 17757294, 17757298, 17757301, 17757302, 17757306, 17757309, 17757312, 17757314, 17757321, 17757332, 17757350, 17757355, 17757358, 17757365, 17757378, 17757382, 17757383, 17757386, 17757388, 17757390, 17757396, 17757397, 17757398, 17757399, 17757400, 17757402, 17757403, 17757404, 17757405, 17757406, 17757408, 17757409, 17757411, 17757414, 17757417, 17757418, 17757419, 17757421, 17757423, 17757424, 17757425, 17757426, 17757428, 17757429, 17757432, 17757433, 17757434, 17757436, 17757438, 17757439, 17757440, 17757441, 17757442, 17757446, 17757448, 17757449, 17757452, 17757456, 17757460, 17757461, 17757462, 17757463, 17757464, 17757466, 17757467, 17757469, 17757472, 17757474, 17757475, 17757476, 17757477, 17757484, 17757486, 17757487, 17757488, 17757489, 17757490, 17757491, 17757493, 17757496, 17757497, 17757504, 17757507, 17757509, 17757511, 17757512, 17757513, 17757514, 17757515, 17757516, 17757520, 17757523, 17757524, 17757527, 17757528, 17757532, 17757538, 17757540, 17757541, 17757543, 17757544, 17757546, 17757548, 17757549, 17757556, 17757559, 17757563, 17757566, 17757568, 17757570, 17757574, 17757589, 17757590, 17757600, 17757607, 17757609, 17757610, 17757623, 17757626, 17757632, 17757635, 17757645, 17757651, 17757657, 17757663, 17757664, 17757669, 17757675, 17757680, 17757684, 17757689, 17757690, 17757696, 17757704, 17757707, 17757710, 17757720, 17757738, 17757742, 17757746, 17757748, 17757751, 17757753, 17757755, 17757757, 17757758, 17757759, 17757761, 17757762, 17757763, 17757767, 17757769, 17757771,
Risk classification
Class I
Area (FDA)
device
Country
United States

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