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Medical Device Recalls
Class 2 Recall
St. Jude Medical CPS Direct SL

See Related Information
Date Recall
Initiated		 June 01, 2006
Date Posted June 24, 2006
Recall Number Z-1166-06
Product CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120, 410121, 410122, 410123, 410124, 410125, & 410126
Code Information All lots with a manufacturing date of May 30, 2006 or earlier
Recalling Firm/
Manufacturer		 St Jude Medical CRMD
15900 Valley View Ct
Sylmar , California 91342-3577
For Addition Information Contact Nestor Kusnierz
818-493-2587
Reason For
Recall		 Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
Action The attached 'Dear Hospital Administrator' letter was sent out to our US sales representatives via FedEx on June 1, 2006. The sales representatives have been instructed to send back all of the devices in their inventory and to retrieve and return any remaining devices that were placed into hospital inventory. They are also instructed to deliver the attached 'Dear Hospital Administrator' letter to the appropriate person at each hospital where product is to be removed from the hospital shelf. .
Quantity in Commerce 6290
Distribution Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
 

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