Devices

Device Recall Sirtex SIRyttrium 90 microspheres (Radionuclide)

Model / Serial
Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10
Product Classification
Radiology Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CT, GA, ID, IL,KY, LA, MD, ME, MO, MT, NJ, NV, WA, and WV.
Product Description
Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. || Indicated for the treatment of unresectable metastatic liver tumors.
Manufacturer
Sirtex Medical Limited
1 Event
- Recall of Device Recall Sirtex SIRyttrium 90 microspheres (Radionuclide)

Manufacturer

Sirtex Medical Limited

Manufacturer Address
Sirtex Medical Limited, Centrecourt Business Park,, Unit D4, 25-27, Paul Street North, North Ryde, New South Wales Australia
Manufacturer Parent Company (2017)
Sirtex Medical Limited
Source
USFDA

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