FDAMay 12, 2025device
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 Li...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Ongoing
Brands named
bd switzerland sarl
UPCs
108854032232041088540322897110885403245022108854032395951088540324093510885403240942108854032710211088540322319810885403240959108854032409971088540322975610885403225628
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV li...2026-05-21
- FDABD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF: 515102 BD PhaSeal Prot...2025-06-16
- FDABD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA2025-05-12
- FDABD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-00062025-05-12
- FDABD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-05002025-05-12
- FDABD 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: MY80602025-05-12
- CPSCBMC Recalls Kaius 01 Bicycles and Framesets Due to Fall Hazard2025-03-13
- FDABD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.2025-02-20
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