FDA (Devices) recall action 95070
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
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.
A software bug in BD Pyxis QFill medication cabinet systems may print incorrect medication bin labels during restocking, potentially causing medication errors. Three units are affected.
The BD Pyxis QFill Replenishment Station medication cabinet has a software issue that may print incorrect bin information on restock labels for medications stored in non-CUBIE locations.