Recall archive / FDA device enforcement
BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore... — FDA record Z-0349-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 11, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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 Micron Filter 2 Blunt Spikes, Catalog # 10062818; BD AlarisTM Pump Infusion Buerette Set SmartSiteTM Port (Burette) 3 SmartSiteTM Y-Sites, Catalog # 10821753; BD AlarisTM Pump Infusion Set 2 Back Check Valves 3 SmartSiteTM Y-Sites, Catalog # 11171447; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog # 11426964; BD AlarisTM Pump Infusion Set 0.2 Micron Filter Back Check Valve Low Sorbing Tubing (PE Lined) 2 SmartSiteTM Y-sites, Catalog # 11532269; BD AlarisTM Pump Infusion Buerette Set 0.2Micron Filter Ball Valve SmartSiteTM Port (Burette) 2 SmartSiteTM Y-Sites, Catalog # 11613191; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog # 10015861A; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM ClosedMale LuerWith PrimingCAP, Catalog # 22000-B007T; BD AlarisTM Pump Infusion Set 1.2 Micron Filter, Catalog # 2202-0007; BD AlarisTM Pump Infusion Set, Catalog # 2204-0007; BD AlarisTM Pump Infusion Set Yellow-Striped Microbore Tubing, Catalog # 2206-0007; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog # 2260-0500; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22600-0007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22601-B007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22602-B007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22603-B007T; BD AlarisTM Pump Infusion Set Back Check Valve SmartSiteTM Y-site, Catalog # 24001-0007; BD AlarisTM Pump Infusion Set Half Set SmartSiteTM Y-site, Catalog # 2403-0007; BD AlarisTMPumpInfusionSetSmartsiteTM BagAcessNon-Vented0.2MicronFilterBo...
- Reason
- Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
- Classification
- Class II
- Recalling firm
- Becton Dickinson & Company
- Quantity
- N/A
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0349-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 10885403232602, Catalog # 10010483; UDI-DI: 07613203021135, Catalog # 10010453; UDI-DI: 07613203015806, Catalog # 10010454; UDI-DI: 07613203021210, Catalog # 10013072; UDI-DI: 10885403221965, Catalog # 10013361; UDI-DI: 10885403232268, Catalog # 10013890; UDI-DI: 10885403233951, Catalog # 10015012; UDI-DI: 10885403221866, Catalog # 10015862; UDI-DI: 07613203019668, Catalog # 10062818; UDI-DI: 07613203019187, Catalog # 10821753; UDI-DI: 07613203021234, Catalog # 11171447; UDI-DI: 10885403232367, Catalog # 11426964; UDI-DI: 10885403232343, Catalog # 11532269; UDI-DI: 10885403276026, Catalog # 11613191; UDI-DI: 10885403232626, Catalog # 10015861A; UDI-DI: 10885403245022, Catalog # 22000-B007T; UDI-DI: 10885403274039, Catalog # 2202-0007; UDI-DI: 10885403199363, Catalog # 2204-0007; UDI-DI: 07613203019224, Catalog # 2206-0007; UDI-DI: 07613203012591, Catalog # 2260-0500; UDI-DI: 10885403239595, Catalog # 22600-0007T; UDI-DI: 10885403240966, Catalog # 22601-B007T; UDI-DI: 10885403240935, Catalog # 22602-B007T; UDI-DI: 10885403240942, Catalog # 22603-B007T; UDI-DI: 10885403238666, Catalog # 24001-0007; UDI-DI: 10885403232473, Catalog # 2403-0007; UDI-DI: 10885403223198, Catalog # 24301-0007T; UDI-DI: 10885403235047, Catalog # 2441-0007; UDI-DI: 10885403235115, Catalog # 2450-0500; ; UDI-DI: 10885403241970, Catalog # 24600-0007; UDI-DI: 10885403240959, Catalog # 24601-B007T; UDI-DI: 10885403221941, Catalog # 2465-0007; UDI-DI: 10885403221958, Catalog # 2466-0007. All lots, expiration date thru July 31, 2026. |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 29, 2023
- Recall initiation date
- Oct 11, 2023
- Center classification date
- Nov 17, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.