Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 51 recalls
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double.…
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Potential for external cassette leaks
Potential for external cassette leaks
Potential for external cassette leaks
Potential for external cassette leaks
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.…
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.…
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded.…
Unreleased software versions were installed on distributed devices without verification or validation.