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Class 2 Device Recall Vaxcel Implantable Chest Ports with PASV Valve Technology |
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Date Initiated by Firm |
September 27, 2006 |
Date Posted |
March 15, 2007 |
Recall Status1 |
Terminated 3 on November 26, 2007 |
Recall Number |
Z-0631-2007 |
Recall Event ID |
37442 |
510(K)Number |
K030083
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Product Classification |
Implantable Vascular Access System - Product Code LJT
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Product |
Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Silicone Catheter, REF/Catalog No. 45-220, UPN/Material No. M001452200, |
Code Information |
Lot 1137368 |
Recalling Firm/ Manufacturer |
Boston Scientific Corp 10 Glens Falls Tech Park Glens Falls NY 12801-3864
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For Additional Information Contact |
Ms. Cindy Finney 508-683-4678
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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.
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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 - 42 |
Distribution |
Nationwide |
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 = LJT and Original Applicant = BOSTON SCIENTIFIC CORP.
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