FDA (Devices) recall action 94937
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CareFusion is recalling approximately 192,964 Alaris Pump Module Model 8100 infusion pumps that may have bent female connectors preventing device operation and delaying patient treatment.
CareFusion's Alaris Syringe Module Model 8110 infusion pumps are being recalled because affected units may have bent female connectors that can prevent device operation and delay infusions. Approximately 20,145 units have been distributed worldwide.
CareFusion 303, Inc. recalls 180 Alaris EtCO2 Module Model 8300 units with potentially bent female connectors that may prevent device operation, risking delays in infusion and monitoring.
CareFusion recalls approximately 10,460 Alaris PCA Module Model 8120 infusion pumps worldwide due to potentially bent female IUI connectors that may prevent proper device operation and delay treatment initiation.
CareFusion's Alaris System PC Unit Model 8015 infusion pumps are being recalled due to a bent female IUI connector affecting over 125,000 devices. The defect may prevent the device from operating properly or delay infusion or monitoring startup.