Drug recall

Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2…

FDA recall event 96737 · Class II · BD SWITZERLAND SARL

Key facts

Event ID 96737
Recall numbers Z-1970-2025, Z-1971-2025, Z-1972-2025, Z-1973-2025, Z-1974-2025
Recalling firm BD SWITZERLAND SARL
Product type Devices
Products 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…, BD 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: MY8060-0006, BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500, BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA, 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
Classification Class II
Status Ongoing
Voluntary or mandated Firm Initiated
Reason for recall 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…
Initiation date May 12, 2025
Report date Jun 18, 2025
City Eysins
Country Switzerland
FEI number 3012798826

At a glance

  • 1–9 Products in this recall
  • None FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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