Z-0093-2024Class II

BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII...

Name: Z-0093-2024 BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII...
Creator: CareFusion 303, Inc.
Published: 2023-09-06
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2023-09-06 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of 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... on 2023-09-06. FDA classified it as Class II and gives the reason as "When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty)...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0093-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-06
Posted: 2023-10-10
Recalling firm: CareFusion 303, Inc
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
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.
Root cause tag: software
FDA root cause: Software change control
Action: On 9/6/23, correction notices were mailed to customers informing them to do the following: 1) Do not use the global edit feature until your software is updated. 2) If a global edit has already been performed, it is recommended to verify that the formulary device settings are accurate for the 4 configuration settings. Controlled substances that have been edited via the global edit feature should be reviewed retrospectively for discrepancies in the destruction bin and a manual witness record may be needed until the settings are adjusted for both "Access Destruction Bin" and "Add to Destruction Bin (count/empty)." 3) Disseminate this notification within your facility network to ensure they are aware of this issue. 4) Complete the attached Customer Response Form and return via email to [email protected] Software patch for v.1.7.3 was released on July 20, 2023, and commercial release software v.1.7.4 was released for on July 31, 2023. Firm will contact customers after the receipt of completed response forms to schedule times to install software update. The following contacts were provided: Technical Support, 1-800-727-6102, 24 hours, 7 days a week; Customer Self Service Portal, https://service.carefusion.com; North American Regional Complaint Center, 1-844-823-5433, Say "Recall" when prompted, Mon-Fri 8:00am and 5:00pm CT, email: [email protected]
Quantity in commerce: 61
Distribution: US Nationwide distribution in the states of LA, NC, NY, MI, MA, NV, KS, IA, CA.
Product codes and lots: REF: 1116-00, UDI-DI: 10885403512605. Software Versions: 1.7.3 and 1.7.4 (Limited commercial release)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0093-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0093-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-10

Product code BRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)