Recall Z-0093-2024 ยท BRY Cabinet, Table And Tray, Anesthesia
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
| Date | Oct 10, 2023 (initiated Sep 6, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 61 |
| Distribution | US Nationwide distribution in the states of LA, NC, NY, MI, MA, NV, KS, IA, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.