# FDA recall Z-0093-2024

> **CareFusion 303, Inc.** · Class II · device recall initiated 2023-09-06.

## 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 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.

## Distribution

US Nationwide distribution in the states of LA, NC, NY, MI, MA, NV, KS, IA, CA.

## Key facts

- **Recall number:** Z-0093-2024
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-06
- **Report date:** 2023-10-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0093-2024

## Citation

> AI Analytics. FDA recall Z-0093-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0093-2024. Source: US FDA. Licensed CC0.

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