Z-1162-2013Class III

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

Name: Z-1162-2013 Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable...
Creator: Sirtex Medical Limited
Published: 2013-02-27
License: https://open.fda.gov/license/

Sirtex Medical Inc. / initiated 2013-02-27 / Terminated / root cause: labeling and UDI

FDA source

Sirtex Medical Limited began a recall of Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors on 2013-02-27. FDA classified it as Class III and gives the reason as "Incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1162-2013
Classification: Class III
Status: Terminated
Initiated: 2013-02-27
Posted: 2013-04-23
Terminated: 2015-03-30
Recalling firm: Sirtex Medical Inc.
Product: Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
Product code: NAW Microspheres Radionuclide
Reason for recall: Incorrect expiration date
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Sirtex notified medical end users on 2/27/13 via email correspondence with a copy of the recall letter attached. This was done to ensure advice was received at the same time that the goods were arriving. Hard copies of the recall letter, which were stamped "copy", were also sent to the individual facilities via UPS, processed for delivery Thursday, 28 February, 2013. Medical end users were advised in the recall letter to contact the US Customer Service staff at (888) 474-7839 x 702 to arrange for the pick-up if they decide to return the unused product.
Quantity in commerce: 21 doses
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 codes and lots: Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1162-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1162-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-23

Product code NAW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)