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Recall Observatory FDA recall evidence

Device product

Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.

Z-1162-2013

February 27, 2013

Class III

Product summary

Firm
Sirtex Medical Limited
Event
Event 64508
Status
Terminated
Classification
Class III
Quantity
21 doses
Official record key
device-enforcement:Z-1162-2013

Official wording

Reason: Incorrect expiration date

Code information: Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect expiration date