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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Event Detail

Event ID 64508
Product Type Devices
Status Completed
Recalling Firm Sirtex Medical Limited
City North Ryde, New South Wales
Country AU
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-27
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors. Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10 Class III Incorrect expiration date 21 doses Z-1162-2013