FDA recall Z-1120-2025

Product

(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

Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia.

Key facts

Status

Ongoing

Initiation date

2025-01-08

Report date

2025-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1120-2025