# FDA recall Z-2180-2025

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

## Product

BD Alaris Pump Infusion Sets    REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV;    REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV;    REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D;    REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV;    REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M;    REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV;    REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV;    REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M;    REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesA

## 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-2180-2025
- **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-2180-2025

## Citation

> AI Analytics. FDA recall Z-2180-2025. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-2180-2025. Source: US FDA. Licensed CC0.

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