The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1579-2023·Announced 2023-05-17

BD Pyxis MedStation ES software failure causes patient data loss

BD Pyxis automated dispensing cabinet software versions 1.7.0 through 1.7.4 experience download failures causing partial loss of patient information and transaction data. This may result in dispensing incorrect medication doses, allergenic medications, or discontinued medications.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving risk-of-harm product with potential for serious medication errors including allergic reactions, incorrect dosing, and dispensing of discontinued medications, though no illnesses or injuries have been reported in the source material.

Plain-English summary

CareFusion 303, Inc. is recalling BD Pyxis MedStation ES, BD Pyxis Anesthesia Station ES, and BD Pyxis CII Safe ES automated dispensing cabinets running software versions 1.7.0 through 1.7.4. Approximately 1,474 units have been distributed in the United States.

The affected software experiences download failures that result in partial loss of patient information and partial loss of patient transaction data, seen as server upload processing errors. The system may display outdated or incorrect information about patient medications.

Due to the missing patient data and inaccurate medication display, healthcare providers may inadvertently dispense medications to which patients are allergic, dispense incorrect medication doses, or dispense medications that have been discontinued. These errors could lead to allergic reactions, dosing errors, or unintended medication exposure.

The recalled product

Product
BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Automated Dispensing Cabinet
Hazard
Affected units
1,474

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 (9)

  • REF/UDI-DI/Software: 323/10885403512667/1.7.0
  • 1.7.1
  • 1.7.2
  • 1.7.3
  • 1.7.4
  • 352/10885403512674/1.7.0
  • 327/10885403477836/1.7.0
  • 1116-00/10885403512605/1.7.0
  • 107-255-01/1.7.0

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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