The FDA issued another Class I recall designation for the BD Alaris from Becton Dickinson (NYSE:BDX), this time for potentially incorrect displays.
Recalled products include the BD Alaris syringe module (model 8110) and BD Alaris PCA module (model 8120), and the BD Alaris syringe/PCA sizer sensor replacement kit (P/N 122786).
Affected products related to the infusion pump, which had a separate Class I recall earlier this week for keypads that may have one or more keys in the keypad that become unresponsive or stuck, were manufactured between March 1, 2010, and the present.
Distribution dates for the affected products range from March 1, 2010, to March 12, 2020. So far, 141,889 devices have been recalled since BD initiated the recall on Aug. 4, 2020, the same date the aforementioned recall was initiated.
The recall was initiated because the affected models may display the incorrect syringe types and/or sizes, which could result in delays in infusion, under-infusion or over-infusion, which could lead to serious adverse events, including death. However, no injuries or deaths have been reported to date.
Clinical users of the affected products have been told to ensure that the displayed syringe manufacturer and syringe size are correctly identifying the installed syringe and, if the PC unit displays an incorrect type and/or size, they are to remove the device from service and send for repair.
