# FDA recall Z-0035-2026

> **CareFusion 303, Inc.** · Class I · device recall initiated 2025-09-11.

## Product

BD Alaris Pump Infusion Sets for the following reference numbers:   C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite  Y-Site  10015414, 180 Micron Filter  2447-0007,  Ball Valve SmartSite Port (Burette) 2 SmartSites  Y-Sites  24201-0007, 2 SmartSite  Y-sites  10012645, Back Check Valve, Non-vented, SmartSite  Y-site    2426-0500, Back Check Valve, 3 SmartSite  Y-sites  2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite  Y-sites  11522558, Ball Valve, Back Check Valve, 3 SmartSite  Y-sites  2410-0500, 2 SmartSite  Y-Sites  2232-0007, 0.2 Micron Filter  11613191, 0.2 Micron Filter, Ball Valve, SmartSite" Port (Burette), 2 SmartSite  Y-sites  10012144, 3 SmartSite Y-Sites, Check Valve  10013034, 3 SmartSite  Y-Sites, Check Valve, 2-Ganged 4-way Stopcock  10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site  11582773, 3 SmartSite  Y-Sites, Check Valve, 2-Ganged 3-way Stopcock

## 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  OUS: United Arab Emirates Australia Belgium Bahrain	 Botswana	 Canada	Switzerland	 China	 France	 United Kingdom Gibraltar	 Israel	India	 Kuwait	 Mexico	Malaysia	 Netherlands	 New Zealand	 Philippines	 Pakistan	 Qatar	 Saudi Arabia	 Singapore	 Taiwan, Province of China	 South Africa

## Key facts

- **Recall number:** Z-0035-2026
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-11
- **Report date:** 2025-10-15

- **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-0035-2026

## Citation

> AI Analytics. FDA recall Z-0035-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0035-2026. Source: US FDA. Licensed CC0.

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