Sirtex Medical Limited

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1275-2021Class IISIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.February 22, 2021
Z-1162-2013Class IIISirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresFebruary 27, 2013