FDA (Devices) recall action 95643
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
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.
An automated medication dispensing cabinet may open the wrong storage pocket due to a software malfunction, potentially leading to incorrect medication removal. The manufacturer is recalling affected units.
The BD Pyxis MedStation ES automated dispensing cabinet may dispense the wrong medication due to a software issue, potentially causing medication errors and inventory shortages.
A software issue in the BD Pyxis CII Safe ES automated dispensing cabinet may cause it to open the wrong medication pocket, risking incorrect medication removal or refills.