Recall Z-1162-2013— Sirtex Medical Limited
Class III · Terminated
Class III FDA medical device recall by Sirtex Medical Limited, initiated 2013-02-27, terminated 2015-03-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.. Reason: Incorrect expiration date.
- Recalling firm
- Sirtex Medical Limited
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-02-27
- Terminated
- 2015-03-30
- Firm location
- North Ryde, New South Wales, Australia
Product description
Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
Reason for recall
Incorrect expiration date
Data sourced from openFDA. This site is unofficial and independent of the FDA.