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

FDA device recall Z-1162-2013 · posted 2013-04-23 · Terminated

Recall details

Recalling firm

Sirtex Medical Limited

Reason for recall

Incorrect expiration date

Action taken

Sirtex notified medical end users on 2/27/13 via email correspondence with a copy of the recall letter attached. This was done to ensure advice was received at the same time that the goods were arriving. Hard copies of the recall letter, which were stamped "copy", were also sent to the individual facilities via UPS, processed for delivery Thursday, 28 February, 2013. Medical end users were advised in the recall letter to contact the US Customer Service staff at (888) 474-7839 x 702 to arrange for the pick-up if they decide to return the unused product.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

NAW

Quantity affected

21 doses

Distribution

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.

Date initiated

2013-02-27

Date posted

2013-04-23

Date terminated

2015-03-30

Location

New South Wales, Australia