BD Pyxis Medication Dispensing Systems Recalled for Insufficient Labeling
CareFusion is recalling six models of BD Pyxis medication management systems due to insufficient labeling regarding potential delays in medication access. The manufacturer is strengthening product labeling to address this risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II device recall addressing a labeling deficiency. No illnesses or injuries have been reported. The hazard involves insufficient information about medication access delays, which the manufacturer is addressing through enhanced labeling rather than product modification.
Plain-English summary
CareFusion 303, Inc. is recalling six models of BD Pyxis medication dispensing and anesthesia management systems totaling approximately 193,067 units. The affected models are the BD Pyxis MedStation ES (Catalog No. 323), BD Pyxis Anesthesia Station (Catalog No. 327), BD Pyxis MedStation ES Tower (Catalog No. 352), BD Pyxis MedStation 4000 Console (Catalog No. 309), BD Pyxis MedStation 4000 (Catalog No. 303), and BD Pyxis Anesthesia System 4000 (Catalog No. 338).
The recall was initiated because the labeling for these systems was insufficient regarding potential delays in access to medication. This labeling deficiency means healthcare providers and institutions may not have adequate information about the devices' limitations in medication dispensing timing.
These devices have been distributed nationwide throughout the United States and internationally to North America, Latin America, EMEA, and Greater Asia. Healthcare facilities using these systems should review updated labeling from the manufacturer to ensure staff understand and account for potential medication access delays when using the equipment.
The recalled product
- 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…
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 193,067
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- (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
- UDI-DI: 10885403512629 (HW)
- 10885403513787 (SW)
- (6) BD Pyxis Anesthesia System 4000
- Catalog No. 338
Distribution
Distributed nationwide across the United States.
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