FDA Medical Device Recalls (openFDA)
Sirtex Medical Limited: Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
- Recall number
- Z-1162-2013
- Recalling firm
- Sirtex Medical Limited
- Product
- Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
- Status
- Terminated
- Initiated
- 2013-02-27
- Posted
- 2013-04-23
- Terminated
- 2015-03-30
- Reason
- Incorrect expiration date
- 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
- 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.
- Lot, serial or model codes
- Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10
- 510(k) numbers
- not on file
- PMA numbers
- ["p990065"]
- Product code
- NAW
- Firm FEI
- 3003428886
- Firm city
- not on file
- Firm state
- New South Wales
- Firm country
- Australia
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28