Z-1325-2009

TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or...

Name: Z-1325-2009 TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or...
Creator: MDS Canada Inc. DBA MDS Nordion
Published: 2009-02-24
License: https://open.fda.gov/license/

Bwxt Medical Ltd. / initiated 2009-02-24 / Terminated / root cause: labeling and UDI

FDA source

MDS Canada Inc. DBA MDS Nordion began a recall of TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in... on 2009-02-24. The reason FDA records is "Instructions for the use of the pinch clamp that is an integral part of the TheraSphere Administration Set were not included with the distribution of the device". 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-1325-2009
Status: Terminated
Initiated: 2009-02-24
Posted: 2009-06-05
Terminated: 2009-06-08
Recalling firm: Bwxt Medical Ltd.
Product: TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.
Product code: NAW Microspheres Radionuclide
Reason for recall: Instructions for the use of the pinch clamp that is an integral part of the TheraSphere Administration Set were not included with the distribution of the device.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: A User Bulletin (TS-2009-1) dated February 23, 2009 was issued to all TheraSphere user sites. The bulletin described the issue, affected units, and recommended actions for users. The bulletin instructed users on the proper use of the pinch clamp. MDS Nordion also updated the package insert with these instructions. For questions about the recall, customers in North America contact MDS Nordion Customer Service at 1-866-363-3330 and customers outside North America call 1-877-474-5999 and request Customer Service. Customers may also e-mail MDS Nordion at [email protected].
Quantity in commerce: 26
Distribution: Worldwide Distribution -- US (states of AZ, CA, CO, FL, IL, IN, KS, MD, MI, NC, RI, OH, OR, PA, WI) and country of Canada.
Product codes and lots: Package Insert Number K120615-023, Rev 9.

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)