Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented… recallZ-1970-2025 · Bd Switzerland Sarl · initiated May 12, 2025

Why it was recalled

Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

FDA root cause category: Process control

What the company is doing

On 5/12/2025, removal notices were mailed or emailed to Medical Director, Risk Manager, Medical Device Safety Officer, Nurse Managers, and Distributors who were asked to do the following: 1. Immediately review your inventory for affected product. Destroy all unused affected products subject to the recall following your institution s process for destruction. 2. Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 3. Complete the Customer Response Form via email to [email protected] 4. In addition, distributors were asked to identify all customers that purchased any affected product and to provide a copy of the customer letter to all customers and to advise them of the removal notification. Report any complaints experienced with the use of this product to the firm's North American Regional Complaint Center: Phone: 1-844-823-5433 Mon-Fri 8:00am and 5:00pm CT, Email: [email protected]

Recall details

Recall number

Z-1970-2025

Status

Open, Classified

Initiated by the company

May 12, 2025

Posted by the FDA

Jun 12, 2025

Recalling firm

Bd Switzerland Sarl

Quantity

2,024,780

Product code

FPA

FDA submissions

K053049

Distribution

Worldwide - US Nationwide distribution including in the states of MA, CA, IL, AK, AL, MO, FL, VA, ME, NC, MD, IA, WI, AZ, CO, KY, IN, TX, AR, NJ, NY, MT, NE, TN, PA, GA, WA, KS, MN, ID, SC, MI, SD, OH, WV, LA, ND, VT, GU, NV, UT, OK, OR, DE, NM, MS, WY and the countries of CA, AU, NZ, CN.

Product description

Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap, REF: 22000-B007T; Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, REF: 22600-0007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22603-B007T; Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites, REF: 24010-0007T; SmartSite Bag Access Non-Vented 0.2 MicronFilter Bonded Texium Closed Low Sorbing Tubing (PE Lined) Male Luer with priming cap SmartSite Y-site, REF: 24301-0007T; SmartSite Bag Access Non-Vented Low Sorbing Texium Back Check Valve 2 SmartSite Y-Sites, REF: 24601-B007T. BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TEXIUMTM AND HANGER LOW SORBING, REF: 70001B-07T; BD 20-IN EXTENSION SET W/0.2 MICRON FILTER ONE SmartSite VALVE AND Texium, REF: 20350ET; BD Secondary Set 20 Drop Vented Non Vented With Texium & Hanger, REF: 40000-07T; BD 20 DROP SECONDARY SET SmartSite VALVE BAG ACCESS W/TEXIUM CLOSED MALE LUER HANGER, REF: 10013364T; BD 32-IN GRAV SET MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, REF: 4030B-07T; BD Texium Smartsite MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T

Devices named in this recall

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

• Alaris, SmartSite, Texium 24301-0007T

  BD Switzerland Sàrl · Set, administration, intravascular
  4 recalls87 reports
• Alaris, SmartSite, Texium 22603-B007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls54 reports
• Alaris, SmartSite, Texium 24010-0007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls54 reports
• Alaris 10013364T

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall141 reports
• Alaris, SmartSite, Texium 24601-B007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls33 reports
• Alaris, SmartSite, Texium 10013361T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls21 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
• BD SmartSite 70001B-07T

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls34 reports
• SmartSite 20350ET

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls12 reports
• BD SmartSite 4030B-07T

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls6 reports
• Alaris, SmartSite, Texium 10321213T

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls2 reports
• BD Texium 40000-07T

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall43 reports
• Texium 22005E-07T

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall0 reports

Product lines

• Alaris, SmartSite, TexiumBD Switzerland Sàrl · 12 models · 291 reports · 5 recalls
• BD SmartSiteBD Switzerland Sàrl · 29 models · 568 reports · 4 recalls
• AlarisBD Switzerland Sàrl · 85 models · 2,797 reports · 10 recalls
• BD TexiumBD Switzerland Sàrl · 7 models · 211 reports · 2 recalls
• SmartSiteBD Switzerland Sàrl · 5 models · 51 reports · 3 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 96737).

• Z-1971-2025 · Open, Classified
  BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
• Z-1973-2025 · Open, Classified
  BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500