Date Initiated by Firm | June 01, 2006 |
Date Posted | June 24, 2006 |
Recall Status1 |
Terminated 3 on March 26, 2012 |
Recall Number | Z-1168-06 |
Recall Event ID |
35616 |
510(K)Number | K053217 |
Product Classification |
Catheter, Percutaneous - Product Code DQY
|
Product | CPS Implant Kit, Model 410190 |
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 CA 91342-3577
|
For Additional Information Contact | Nestor Kusnierz 818-493-2587 |
Manufacturer 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. |
FDA Determined Cause 2 | Other |
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 | 831 |
Distribution | Hospitals/Medical Centers in AZ, CA, MS, NY, & PA |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DQY
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