FDA Device recall Z-2448-2024

Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12…

FDA Device
Class I
ongoing
Published 2024-08-21

On 2024-08-21 the FDA classified a Class I recall of Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12… by Icu Medical, citing 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 ru….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2448-2024
Classification	Class I
Status	ongoing
Initiated	2024-05-07
Published	2024-08-21
Last updated	2026-09-13 11:57 UTC
Company	Icu Medical
Distribution	US

Product

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

Reason

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.

Identifiers

code_info	1. Product Code: 206782284. No UDI Number (Serial Numbers: 16095234, 18077407, 18077421, 18077507, 18077551, 18077561,… 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,

code_info

1. Product Code: 206782284. No UDI Number (Serial Numbers: 16095234, 18077407, 18077421, 18077507, 18077551, 18077561,…

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,

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-2448-2024%22

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