Devices

FDA Classifies 4 Recent BD Alaris Pump Recalls

Becton, Dickinson says four previously announced recalls of its BD Alaris System have been classified as follows:

Alaris PC Unit Model 8015 Front Case with Keypad Replacement Kits (Class 1 recall): The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress, potentially resulting in a delay to the start of infusion, interruption of infusion or inability to titrate medication.
Alaris Pump Module Model 8100 Front Case with Keypad Replacement Kits (Class 1 recall): Pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress, potentially resulting in a delay to the start of infusion or interruption of infusion.
BD Alaris Syringe Module Model 8110 and PCA Module Model 8120 (Class 1 recall: The Alaris PC unit may display incorrect syringe type or syringe sizes. This could potentially result in delays in infusion, under-infusion or over-infusion.
BD Alaris EtCO2 Module model 8300 channel error (Class 2 recall) Infusion pump component defect may result in interruption of patient monitoring.

The recalls were announced by the company in August.

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