| | Class 3 Recall
TheraSphere |  |
| Date Posted |
June 05, 2009 |
| Recall Number |
Z-1325-2009 |
| 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. |
| Code Information |
Package Insert Number K120615-023, Rev 9.
|
Recalling Firm/
Manufacturer |
MDS Canada Inc. DBA MDS Nordion
447 March Road
Ottawa, Ontario |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Janet Bukovcan
613-592-3400 Ext. 2306
|
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.
|
| 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 TheraSphere@mdsinc.com. |
| 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. |
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