# FDA recall Z-0349-2024

> **Becton Dickinson & Company** · Class II · device recall initiated 2023-10-11.

## Product

BD Alaris Pump infusion sets (Product Name, Catalog #)    BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog #  10010483;   BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog #  10010453;   BD AlarisTM Pump Infusion Set 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog #  10010454;   BD AlarisTM Pump Infusion Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSiteTM Y-sites, Catalog #  10013072;   BD AlarisTM Bag Access Non-Vented Back Check Valve 2 SmartSiteTM Y-Sites, Catalog #  10013361;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  10013890;   BD AlarisTM Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSiteTM Port (Burette) SmartSiteTM Y-Site, Catalog #  10015012;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE-Lined), Catalog #  10015862;   BD AlarisTM Pump Infusion Blood Set 180 Micr

## Reason for recall

Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

## Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WY, Puerto Rico, Guam; and the countries of Australia, Brazil, Canada, Dominican Republic, India, Kuwait, Mexico, New Zealand, Philippines, Poland, Saudi Arabia, Singapore, Taiwan, United Arab Emirates.

## Key facts

- **Recall number:** Z-0349-2024
- **Recalling firm:** Becton Dickinson & Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-11
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Franklin Lakes, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0349-2024

## Citation

> AI Analytics. FDA recall Z-0349-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0349-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*