ICU Medical Plum Solos, Item number 400011001; infusion pump

Class I - Dangerous

🏥 Medical Devices Recalled: April 22, 2025 ICU Medical Infusion Pumps Nationwide

What Should You Do?

Check if you have this product:
UDI/DI N/A, Serial/Lot Numbers: 60000001, 60000002, 60000003, 60000005, 60000006, 60000007, 60000008, 60000009, 60000010, 60000011, 60000014, 60000015, 60000016, 60000017, 60000019, 60000020, 60000021, 60000023, 60000024, 60000025, 60000026, 60000027, 60000028, 60000030, 60000032, 60000033, 60000035, 60000038, 60000039, 60000040, 60000041, 60000042, 60000044, 60000045, 60000046, 60000047, 60000048, 60000049, 60000050, 60000051, 60000052, 60000053, 60000054, 60000056, 60000057, 60000058, 60000059, 60000060, 60000061, 60000062, 60000063, 60000064, 60000065, 60000066, 60000067, 60000068, 60000069, 60000070, 60000071, 60000072, 60000073, 60000074, 60000075, 60000076, 60000077, 60000078, 60000079, 60000080, 60000081, 60000082, 60000083, 60000084, 60000085, 60000087, 60000088, 60000089, 60000090, 60000092, 60000093, 60000094, 60000095, 60000096, 60000097, 60000098, 60000099, 60000100, 60000101, 60000102, 60000104, 60000105, 60000107, 60000108, 60000109, 60000110, 60000112, 60000113, 60000114, 60000120, 60000130, 60000133, 60000134, 60000136, 60000139, 60000141, 60000143, 60000147, 60000150, 60000154, 60000159, 60000160, 60000162, 60000165, 60000167, 60000170, 60000171, 60000172, 60000173, 60000174, 60000176, 60000177, 60000178, 60000179, 60000180, 60000183, 60000187, 60000189, 60000190, 60000191, 60000192, 60000198, 60000199, 60000201, 60000203, 60000204, 60000205, 60000206, 60000207, 60000208, 60000209, 60000210, 60000212, 60000213, 60000214, 60000215, 60000216, 60000217, 60000223, 60000224, 60000225, 60000226, 60000227, 60000228, 60000229, 60000230, 60000234, 60000236, 60000237, 60000238, 60000239, 60000240, 60000241, 60000242, 60000244, 60000245, 60000246, 60000247, 60000249, 60000251, 60000252, 60000255, 60000257, 60000259, 60000263, 60000264, 60000265, 60000266, 60000268, 60000269, 60000271, 60000273, 60000274, 60000275, 60000276, 60000277, 60000279, 60000280, 60000281, 60000282, 60000283, 60000284, 60000285, 60000286, 60000288, 60000291, 60000292, 60000295, 60000296, 60000297, 60000298, 60000300, 60000155, 60000193, 60000197, 60000211, 60000243, 60000270, 60000272, 60000123, 60000168, 60000175, 60000195, 60000221, 60000256, 60000294.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: ICU Medical, Inc.
Reason for Recall:: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

ICU Medical Plum Solos, Item number 400011001; infusion pump

Product Codes/Lot Numbers:

UDI/DI N/A, Serial/Lot Numbers: 60000001, 60000002, 60000003, 60000005, 60000006, 60000007, 60000008, 60000009, 60000010, 60000011, 60000014, 60000015, 60000016, 60000017, 60000019, 60000020, 60000021, 60000023, 60000024, 60000025, 60000026, 60000027, 60000028, 60000030, 60000032, 60000033, 60000035, 60000038, 60000039, 60000040, 60000041, 60000042, 60000044, 60000045, 60000046, 60000047, 60000048, 60000049, 60000050, 60000051, 60000052, 60000053, 60000054, 60000056, 60000057, 60000058, 60000059, 60000060, 60000061, 60000062, 60000063, 60000064, 60000065, 60000066, 60000067, 60000068, 60000069, 60000070, 60000071, 60000072, 60000073, 60000074, 60000075, 60000076, 60000077, 60000078, 60000079, 60000080, 60000081, 60000082, 60000083, 60000084, 60000085, 60000087, 60000088, 60000089, 60000090, 60000092, 60000093, 60000094, 60000095, 60000096, 60000097, 60000098, 60000099, 60000100, 60000101, 60000102, 60000104, 60000105, 60000107, 60000108, 60000109, 60000110, 60000112, 60000113, 60000114, 60000120, 60000130, 60000133, 60000134, 60000136, 60000139, 60000141, 60000143, 60000147, 60000150, 60000154, 60000159, 60000160, 60000162, 60000165, 60000167, 60000170, 60000171, 60000172, 60000173, 60000174, 60000176, 60000177, 60000178, 60000179, 60000180, 60000183, 60000187, 60000189, 60000190, 60000191, 60000192, 60000198, 60000199, 60000201, 60000203, 60000204, 60000205, 60000206, 60000207, 60000208, 60000209, 60000210, 60000212, 60000213, 60000214, 60000215, 60000216, 60000217, 60000223, 60000224, 60000225, 60000226, 60000227, 60000228, 60000229, 60000230, 60000234, 60000236, 60000237, 60000238, 60000239, 60000240, 60000241, 60000242, 60000244, 60000245, 60000246, 60000247, 60000249, 60000251, 60000252, 60000255, 60000257, 60000259, 60000263, 60000264, 60000265, 60000266, 60000268, 60000269, 60000271, 60000273, 60000274, 60000275, 60000276, 60000277, 60000279, 60000280, 60000281, 60000282, 60000283, 60000284, 60000285, 60000286, 60000288, 60000291, 60000292, 60000295, 60000296, 60000297, 60000298, 60000300, 60000155, 60000193, 60000197, 60000211, 60000243, 60000270, 60000272, 60000123, 60000168, 60000175, 60000195, 60000221, 60000256, 60000294.