# FDA recall Z-1231-2025

> **CareFusion 303, Inc.** · Class II · device recall initiated 2025-01-23.

## Product

BD Alaris Pump Module REF 8100    The BD Alaris 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

## Reason for recall

Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set.  This issue potentially could result in an accidental over infusion if the roller clamp is left open.

## Distribution

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Guantanamo Bay, Cuba  O.U.S.: Canada

## Key facts

- **Recall number:** Z-1231-2025
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-23
- **Report date:** 2025-03-05

- **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-1231-2025

## Citation

> AI Analytics. FDA recall Z-1231-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1231-2025. Source: US FDA. Licensed CC0.

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