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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Detail

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

Event Detail

Event Id 64508
Product Type Devices
Status Completed
Recalling Firm Sirtex Medical Limited
City North Ryde, New South Wales
State
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.
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