FDA Medical devices recall ·
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium… recall
- Recall number
- Z-1970-2025
- Date
- (initiated May 12, 2025)
- Company / brand
- Bd Switzerland Sarl
Terre Bonne Park A4, Eysins, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,024,780
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF/UDI-DI/Lot(Expiration): 10013361T/10885403223204/23025303(February 10, 2026), 23035235(March 11, 2026), 23045223(April 6, 2026), 23075395(July 17, 2026), 23085227(August 8, 2026), 23115150(November 8, 2026), 23115151(November 8, 2026), 23125167(December 5, 2026), 24025684(February 6, 2027), 24045377(April 23, 2027), 24055576(May 27, 2027), 24075224(July 26, 2027), 24105079(October 11, 2027), 24115159(November 7, 2027); 10321213T/10885403228971/23035169(March 15, 2026), 23045174(April 4, 2026), 23085140(August 3, 2026), 23095142(September 11, 2026), 23105297(October 12, 2026), 24025686(February 6, 2027); 22000-B007T/10885403245022/23025320(February 13, 2026), 23045224(April 11, 2026), 23065209(June 10, 2026), 23075394(July 21, 2026), 23095143(September 11, 2026), 23105133(October 6, 2026), 24015278(January 13, 2027), 24025685(February 6, 2027), 24036209(March 25, 2027), 24075260(July 26, 2027), 24066653(June 24, 2027); 22600-0007T/10885403239595/23095151(September 11, 2026), 24036205(March 25, 2027), 24055601(May 27, 2027); 22602-B007T/10885403240935/23045501(April 20, 2026), 23095152(September 11, 2026), 24015186(January 9, 2027), 24026152(February 27, 2027), 24036206(March 25, 2027), 24045384(April 23, 2027), 24115032(November 2, 2027); 22603-B007T/10885403240942/23035482(March 23, 2026), 23035504(March 25, 2026), 23055379(May 23, 2026), 23065210(June 12, 2026), 23075056(July 13, 2026), 23085141(August 3, 2026), 23095808(September 14, 2026), 23105296(October 12, 2026), 2
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.
States: Alaska Alabama Arkansas Arizona California Colorado Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1970-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.