Infusion Pumps

Products distributed as sterile may not have been adequately sterilized

Products distributed as sterile may not have been adequately sterilized

Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active insulin and delivers an additional bolus, there is a risk of insulin over delivery.

Products distributed as sterile may not have been adequately sterilized

Products distributed as sterile may not have been adequately sterilized

Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

Products distributed as sterile may not have been adequately sterilized

Products distributed as sterile may not have been adequately sterilized

Products distributed as sterile may not have been adequately sterilized

Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active insulin and delivers an additional bolus, there is a risk of insulin over delivery.

Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.

Products distributed as sterile may not have been adequately sterilized

Removing parts for safety reasons due to possible breakage.

Due to a failure of the welds, the casters detached from the rear legs of the walker.

There is a potential leak between the venous patient connector and patient's hemodialysis access.

Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.

Products labeled as sterile were distributed, but may not have been sterilized.

Products labeled as sterile were distributed, but may not have been sterilized.

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.