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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 22, 2005
Date Posted September 02, 2005
Recall Status1 Terminated 3 on June 20, 2007
Recall Number Z-1497-05
Recall Event ID 32694
510(K)Number K032712  
Product Classification Catheter, Suprapubic (And Accessories) - Product Code KOB
Product Vaxcel¿ Plus Chronic Dialysis Catheters - Kit/CPU/15/28/Metal
Catalog Number : 45-550
Code Information Lot Numbers: 983682 985888 1013921  1018977 1022506 1027125   
Recalling Firm/
Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Cindy Finney
Manufacturer Reason
for Recall
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
FDA Determined
Cause 2
Action Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.
Distribution Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KOB and Original Applicant = BOSTON SCIENTIFIC CORP.