BD SWITZERLAND SARL

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2453-2025Class IIBD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PJune 16, 2025
Z-1971-2025Class IIBD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF:May 12, 2025
Z-1970-2025Class IIAlaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back CheckMay 12, 2025
Z-1974-2025Class IIBD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINAMay 12, 2025
Z-1973-2025Class IIBD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500May 12, 2025
Z-1972-2025Class IIBD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY80May 12, 2025
Z-1509-2025Class IIBD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and ConnectFebruary 20, 2025
Z-1944-2024Class IIAlaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 100April 18, 2024
Z-1967-2020Class IIBD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog NApril 9, 2020
Z-1968-2020Class IIBD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog NApril 9, 2020
Z-1969-2020Class IIBD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog NApril 9, 2020