# FDA recall Z-2179-2025

> **CareFusion 303, Inc.** · Class I · device recall initiated 2025-07-08.

## Product

BD Alaris Pump Module Model, 8100  with Guardrails, Suite MX software versions

## Reason for recall

Infusion pump module used with compatible  pump infusion sets  may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

## Distribution

US Nationwide Distribution to states of: AK	AL	AR	AS	AZ	CA	CO	CT	DC	DE	FL	GA	GU	HI	IA	ID	IL	IN	KS	KY	LA	MA	MD	ME	MI	MN	MO	MP	MS	MT	NC	ND	NE	NH	NJ	NM	NV	NY	OH	OK	OR	PA	PR	RI	SC	SD	TN	TX	UT	VA	VT	WA	WI	WV	WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey

## Key facts

- **Recall number:** Z-2179-2025
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-08
- **Report date:** 2025-08-13

- **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-2179-2025

## Citation

> AI Analytics. FDA recall Z-2179-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2179-2025. Source: US FDA. Licensed CC0.

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