ICU Medical

One lot of ICU Medical 0.9% Sodium Chloride Injection (a salt solution) was found to contain 10 mEq Potassium Chloride Injection instead. The vial had the correct outer label but the wrong product inside. This was discovered through a customer complaint.

ICU Medical's Hotline Fluid Warming Set (model L-70), a single-use device used to warm blood and IV fluids before delivery to patients, may leak due to inadequate solvent application at the tubing-to-connector bond in certain production lots. This defect could affect proper fluid delivery during patient care.

In certain conditions, the Plum Solo Precision IV pump (v1.0.3) may not properly track the volume of fluid being delivered and could administer up to twice the intended amount of medication or fluid. This affects specific serial numbers of the pump.

Certain ICU Medical Plum Duo infusion pumps may fail to track the amount of fluid delivered on the screen display. In rare cases, this could cause the pump to deliver up to twice the intended volume of medication or fluid. This affects specific serial numbers of two item numbers (400020401 and 400020403) running software version 1.2.3.

The Plum Duo Precision IV Pump may fail to display a soft limit alert under certain conditions, meaning clinicians won't be notified before the pump starts delivering medication that exceeds the set safety limit. This could result in patients receiving too much or too little medication.

The Plum Duo Infusion Pump may fail to display alerts when medication delivery limits are exceeded. Without these warnings, clinicians may not know before the pump starts delivering the wrong amount of medication to a patient.

The Plum Solo Precision IV Pump may fail to display a soft limit alert under certain conditions, preventing clinicians from being notified of dosage limit violations before the pump starts delivery. This could result in incorrect medication doses being administered.

ICU Medical oncology infusion kits with extension sets may develop leaks during chemotherapy administration. If a leak occurs during therapy, patients may receive less medication than intended, and healthcare workers or patients could be exposed to hazardous drugs.

ICU Medical's Plum Solo and Duo Infusion pumps have a software issue that may prevent clinicians from programming an automatic line flush after piggyback therapy. In certain situations, the pump displays an error message that blocks the flush from being set up, even though the flush is a normal part of the treatment process.

ICU Medical's Plum Duo Precision IV Pump may prevent clinicians from programming an automatic flush after piggyback therapy in certain situations. When this happens, the pump displays an error message and the flush cannot be set up, which could affect how medications are delivered.

ICU Medical Plum Solo and Duo Infusion pumps have a software issue that may prevent clinicians from programming an automatic flush after piggyback therapy. When attempting to set up this flush feature, the pump may display an error message that blocks the programming, even though the flush itself is a safe feature.

ICU Medical's Tego Connector needle-free access devices have a silicone seal that may bulge, separate, or tear. This defect can cause fluid leaks, blockages, inability to draw or inject medication, and potential exposure to contamination or air in the bloodstream during hemodialysis or IV therapy.

Certain batches of syringes in ICU Medical's Portex Spinal Tray may have cracks in the syringe collar. This defect can prevent the syringe from working properly, cause repeated blood draws, or lead to blood leakage during arterial blood sampling or fluid delivery.

ICU Medical Inc. is recalling specific lots of Pulsator Arterial Blood Sampling Kits because some syringes have cracks in the collar. This crack can cause blood to leak during sampling, delays in blood draws, or the need to repeat the procedure.

ICU Medical identified a batch of defective speakers in some Plum Duo Infusion Pumps that may fail silently. If the speaker fails, the pump will not produce audible alarms, alerts, or sound feedback when you touch the screen. This could delay recognition of important pump notifications.

ICU Medical's LifeShield Infusion Safety Software v2.2 has a software issue that limits concentration settings to one decimal place instead of three. This may force users to set drug limits differently than the manufacturer recommends, potentially causing patients to receive too much or too little medication.

ICU Medical's LifeShield Drug Library Management software version 2.2.1 has a problem where the Change Summary review tool stops working correctly after a library migration. This affects only customers who upgraded from version 2.1x and use Plum Duo v1.1 infusion pumps. When the review tool doesn't work, staff may not catch errors in pump settings.

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.