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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm March 05, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 26, 2005
Recall Number Z-0759-04
Recall Event ID 28533
510(K)Number K974640  
Product Classification Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
Product VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-988. Firm on the label: Boston Scientific.
Code Information 912502, Exp. 10/31/05
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Nancy Cutino
508-652-5066
Manufacturer Reason
for Recall		 Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.
FDA Determined
Cause 2		 Other
Action Letter dated 3/5/04 with instructions to return product.
Quantity in Commerce 75 units (box/10)
Distribution 42 domestic hospitals nationwide and one distributor in Canada.
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 = DRE and Original Applicant = BOSTON SCIENTIFIC CORP.
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