Infusion Pumps

Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.

For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.

Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.

Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.

Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, which may not provide adequate protection against impact, posing a risk of eye injury.

Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.

ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.

Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

A limited number of IV bags have been found to leak during filling.

A limited number of IV bags have been found to leak during filling.

The door on the Spectrum IQ Infusion pump may not be able to fully close.

A limited number of IV bags have been found to leak during filling.

A limited number of IV bags have been found to leak during filling.

A limited number of IV bags have been found to leak during filling.

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

A limited number of IV bags have been found to leak during filling.

A limited number of IV bags have been found to leak during filling.

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.