CareFusion 303, Inc.: (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 40

Hazard

Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.

Details from the source

Reason for recall: Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation. Distribution: Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia. Quantity: 193067 Lot/code info: (1)BD Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) BD Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; ALL serial numbers; software versions v1.10 and prior. (4) BD Pyxis MedStation 4000 Console, Catalog No. 309, All serial numbers and all software versions, UDI-DI: 10885403512636; (5) BD Pyxis MedStation 4000, Catalog No. 303, All serial numbers and all software versions, UDI-DI: 10885403512629 (HW), 10885403513787 (SW); (6) BD Pyxis Anesthesia System 4000, Catalog No. 338, All serial numbers and all software versions, UDI-DI: 10885403477829 (HW), 10885403513787 (SW)

UPC codes

10885403512667, 10885403477836, 10885403512674, 10885403512636, 10885403512629, 10885403513787, 10885403477829

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.