FDA Device recall Z-0093-2024
BD Pyxis CII Safe ES, REF: 1116-00
- FDA Device
- Class II
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class II recall of BD Pyxis CII Safe ES, REF: 1116-00 by Carefusion 303, citing 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)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0093-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-06 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carefusion 303 |
| Distribution | US |
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
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.
Identifiers
| code_info | REF: 1116-00, UDI-DI: 10885403512605. Software Versions: 1.7.3 and 1.7.4 (Limited commercial release) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0093-2024%22
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