The Recall Desk
HighFDA (Devices)·Z-0093-2024·Announced 2023-10-18

BD Pyxis CII Safe ES Software Flaw Disables Controlled Substance Safeguards

Certain BD Pyxis CII Safe ES software versions (1.7.3 and 1.7.4) can silently disable critical controlled substance tracking safeguards when multiple settings are updated at once, potentially allowing diversion. No incidents have been reported.

What this means for you

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 device with a real risk of controlled substance diversion due to disabled tracking safeguards. No illnesses, injuries, or confirmed diversions have been reported, making this a risk-of-harm device without reported injury, fitting Severity 3 (High) per the rubric.

Plain-English summary

The BD Pyxis CII Safe ES is an automated dispensing cabinet system manufactured by CareFusion 303, Inc., used in healthcare facilities to secure and track controlled substances.

A software issue has been identified affecting software versions 1.7.3 and 1.7.4 (limited commercial release). When the global edit function is used to update multiple formulary properties simultaneously, four critical safety features are silently overwritten to a disabled state without user warning: (1) Require Lot Number on Recall, (2) Access Destruction Bin (Witness), (3) Add to Destruction Bin (Count/Empty), and (4) CII Safe Stock Out Notice. This could result in diversion of controlled substances from the dispensing cabinet.

Approximately 61 units have been distributed nationwide across Louisiana, North Carolina, New York, Michigan, Massachusetts, Nevada, Kansas, Iowa, and California.

Healthcare facilities operating affected units should review their inventory of controlled substances and confirm that all critical safeguards are enabled. Contact CareFusion 303, Inc. for information on software updates and corrective measures.

The recalled product

Product
BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Automated Dispensing System
Hazard
  • substance-diversion
  • software-flaw

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 (1)

  • REF: 1116-00

Distribution

Distributed nationwide across the United States.

Related recalls

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