ICU Medical Inc: 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, 1234

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 14,744 units Lot/code info: 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, 1

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.