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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmOctober 28, 2005
Date PostedJanuary 06, 2006
Recall Status1 Terminated 3 on February 15, 2007
Recall NumberZ-0342-06
Recall Event ID 33858
510(K)NumberK962300 
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
ProductSilicone 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
For Additional Information ContactCindy 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
ActionBoston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.
Quantity in Commerce454 units
DistributionDOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan
Total Product Life CycleTPLC Device Report

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.
510(K) Database510(K)s with Product Code = LJS
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