# FDA recall Z-1217-2026

> **CareFusion 303, Inc.** · Class II · device recall initiated 2025-11-06.

## Product

BD Alaris" Pump Module model 8100  UDI-DI code: 10885403810046    The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces.    The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.

## Reason for recall

Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST  invalid  timestamp, impacting connectivity of the PCU to the hospital network

## Distribution

U.S. Nationwide distribution in the states of AZ, IN, OH, and VA.

## Key facts

- **Recall number:** Z-1217-2026
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-06
- **Report date:** 2026-02-04

- **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-1217-2026

## Citation

> AI Analytics. FDA recall Z-1217-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1217-2026. Source: US FDA. Licensed CC0.

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