Sirtex Medical Limited: Medical Device Recall in 2013 - (Recall #: Z-1162-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.

Product Classification:

Class III

Date Initiated: February 27, 2013

Date Posted: May 1, 2013

Recall Number: Z-1162-2013

Event ID: 64508

Reason for Recall:

Incorrect expiration date

Status: Terminated

Product Quantity: 21 doses

Code Information:

Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated