BEUDAMED
    FDA Recall Terminated

    Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150,

    Recall: Z-0630-2007 · Initiated September 27, 2006

    Recall

    Recall Number
    Z-0630-2007
    Event Number
    37442
    Firm
    Boston Scientific Corp
    FEI Number
    3017892510
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2006
    Posted
    March 15, 2007
    Terminated
    November 26, 2007
    Address
    10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864

    Description

    Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150,

    Reason

    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.

    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.

    Distribution

    Nationwide

    Quantity

    Domestic - 194