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U.S. Department of Health and Human Services

Class 2 Device Recall Vaxcel Implantable Chest Ports with PASV Valve Technology

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  Class 2 Device Recall Vaxcel Implantable Chest Ports with PASV Valve Technology see related information
Date Initiated by Firm September 27, 2006
Date Posted March 15, 2007
Recall Status1 Terminated 3 on November 26, 2007
Recall Number Z-0630-2007
Recall Event ID 37442
510(K)Number K030083  
Product Classification Implantable Vascular Access System - Product Code LJT
Product Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150,
Code Information Lots 1137363, 1137364, 1137733, and 1137734
Recalling Firm/
Manufacturer		 Boston Scientific Corp
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact Ms. Cindy Finney
508-683-4678
Manufacturer Reason
for Recall		 Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised.
FDA Determined
Cause 2		 Other
Action On 9/27/06, Boston Scientific Corp. sent Urgent Medical Device Recall - Immediate Action Required letters (dated 9/27/06) via Federal Express to the 84 end users (medical facilities). The letters informed the users of the recall of the products due to a compromised sterile barrier. The letters instructed the users to immediately remove the affected lots from inventory, segregate them, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, return the product in an appropriate shipping carton, place the label on the outside of the shipping box, write the RGA # on the outside of the shipping carton, and return the recalled product to Boston Scientific Corp. Distribution Center, Attn: QA Returns, 500 Commander Shea Blvd., Quincy, MA 02171. Accompanying each letter was a Reply Verification Tracking Form to be completed by the user, and mailed or faxed back to Boston Scientific.
Quantity in Commerce Domestic - 194
Distribution Nationwide
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 = LJT and Original Applicant = BOSTON SCIENTIFIC CORP.
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