BD Alaris Pump infusion sets (Product Name, Catalog #) recallZ-0349-2024 · Becton Dickinson & Company · initiated Oct 11, 2023

Why it was recalled

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

FDA root cause category: Error in labeling

What the company is doing

BD sent initial letters for this recall on October 11, 2023. A second notification was made available to customers on November 1, 2023 providing customers with additional information related to risk and recommended customer actions. In addition, the customer notification identified one additional product code that is in scope of this advisory. BD has identified that the infusion sets listed in Appendix 1 of the customer notification contain di(2-ethylhexyl) phthalate (DEHP) and have not been labelled accordingly. This could lead to the potential risk of DEHP exposure that may have short-term and long-term harmful effects. BD recommends using DEHP-free devices when specified by drug manufacturers. For devices in-situ with patients requiring a DEHP-free treatment, BD instructs to cease use and an alternate treatment or device be sourced. BD will be updating the labelling for these devices to state Contains or presence of phthalate: DEHP. Circulate this notice to all who need to be aware within your organization and to any organization affected devices have been further distributed to. Return the customer response from to BD whether or not you have any of the impacted material. Report any issues experienced with these devices to BD as a complaint as per your normal process. Phone: (844) 823-5433, Mon Fri 8:00am and 5:00pm CT, or Email: [email protected]. Any adverse health consequences experienced may also be reported to the FDA's MedWatch Adverse Event Reporting program.

Recall details

Recall number

Z-0349-2024

Status

Open, Classified

Initiated by the company

Oct 11, 2023

Posted by the FDA

Nov 17, 2023

Recalling firm

Becton Dickinson & Company

Product code

FPA

FDA submissions

K022209

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.

Product description

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-Vented0.2MicronFilterBondedTexiumTMClosedLowSorbingTubing(PELined)MaleLuerwithprimingcapSmartSiteTMY-site, Catalog # 24301-0007T; BD AlarisTM Pump Infusion Buerette Set Smallbore Tubing SmartsiteTM Port (Burette) 3 SmartSiteTM Y-Site, Catalog # 2441-0007; BD AlarisTM Pump Infusion Set Back Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSiteTM Y-sites, Catalog # 2450-0500; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog # 24600-0007; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing TexiumTM Back Check Valve 2 SmartSiteTM Y-sites, Catalog # 24601-B007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-Site, Catalog # 2465-0007; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined), Catalog # 2466-0007.

Devices named in this recall

33 devices in the FDA device registry whose identifier appears in the recall's code information.

• Alaris, SmartSite 11532269

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls332 reports
• Alaris, SmartSite 10010454

  BD Switzerland Sàrl · Set, administration, intravascular
  4 recalls212 reports
• Alaris 2202-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls248 reports
• Alaris, SmartSite 10010453

  BD Switzerland Sàrl · Set, administration, intravascular
  4 recalls165 reports
• Alaris, SmartSite, Texium 24301-0007T

  BD Switzerland Sàrl · Set, administration, intravascular
  4 recalls87 reports
• Alaris, SmartSite 11171447

  BD Switzerland Sàrl · Set, administration, intravascular
  4 recalls77 reports
• Alaris, SmartSite 10015012

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls87 reports
• Alaris 2204-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls59 reports
• Alaris 10010483

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls59 reports
• Alaris, SmartSite, Texium 22603-B007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls54 reports
• Alaris, SmartSite 2441-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls97 reports
• Alaris 2260-0500

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls96 reports
• Alaris, SmartSite 2465-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls45 reports
• Alaris, SmartSite 10013072

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls33 reports
• Alaris, SmartSite, Texium 24601-B007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls33 reports
• Alaris, SmartSite 10015861A

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls80 reports
• Alaris, SmartSite, Texium 22000-B007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls10 reports
• Alaris, SmartSite, Texium 22602-B007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls8 reports
• Alaris, Texium 22600-0007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls1 report
• Alaris 10062818

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls34 reports
• Alaris 11426964

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls22 reports
• Alaris, SmartSite 10015862

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls21 reports
• Alaris, SmartSite 24600-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls19 reports
• Alaris, SmartSite 10013361

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls9 reports
• Alaris 10013890

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls8 reports
• Alaris, SmartSite 10821753

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls5 reports
• Alaris, SmartSite 24001-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls2 reports
• Alaris 2206-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls1 report
• Alaris, SmartSite 2466-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls1 report
• Alaris, SmartSite 2403-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls1 report
• Alaris, SmartSite 11613191

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls0 reports
• Alaris, SmartSite, Texium 22601-B007T

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall4 reports
• Alaris, SmartSite 2450-0500

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall3 reports

Product lines

• Alaris, SmartSiteBD Switzerland Sàrl · 160 models · 10,227 reports · 8 recalls
• AlarisBD Switzerland Sàrl · 85 models · 2,797 reports · 10 recalls
• Alaris, SmartSite, TexiumBD Switzerland Sàrl · 12 models · 291 reports · 5 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 93266).

• Z-0350-2024 · Open, Classified
  BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DRO…
• Z-0351-2024 · Open, Classified
  BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog …