Z-1120-2025 Class II Ongoing
FDA device recall Z-1120-2025 was initiated by CareFusion 303, Inc. on January 8, 2025 and is designated Class II. Reason for recall: Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation. The recall status is ongoing. Affected quantity: 193067.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2025
- Initiation Date
- January 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 193067
Product Description
(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 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338
Reason for Recall
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
Distribution Pattern
Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia.
Code Information
(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)