| Class 2 Device Recall | |
Date Initiated by Firm | October 28, 2005 |
Date Posted | January 06, 2006 |
Recall Status1 |
Terminated 3 on February 15, 2007 |
Recall Number | Z-0342-06 |
Recall Event ID |
33858 |
510(K)Number | K962300 |
Product Classification |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
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Product | Silicone Central Venous Catheters with PASV Valve and Polyester Cuff - 7F. Boston Scientific Cat. #CVC702IK, M001CVC702IKO. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801. |
Code Information |
1009522, 1009825, 1012337, 1013926, 1017134, 1017763, 1018161, 1018456, 1022953 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Boston Scientific Pl Natick MA 01760-1536
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For Additional Information Contact | Cindy Finney 508-683-4678 |
Manufacturer Reason for Recall | Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths. |
FDA Determined Cause 2 | Other |
Action | Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product. |
Quantity in Commerce | 454 units |
Distribution | DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan |
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 = LJS
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