CareFusion 303, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
CareFusion 303, Inc.
Lot Codes / Batch Numbers
REF: 1116-00, UDI-DI: 10885403512605. Software Versions: 1.7.3 and 1.7.4 (Limited commercial release)
Products Sold
REF: 1116-00, UDI-DI: 10885403512605. Software Versions: 1.7.3 and 1.7.4 (Limited commercial release)
CareFusion 303, Inc. is recalling BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254- due to When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 bdrc44@bd.com 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: productcomplaints@bd.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026