BEUDAMED
    FDA Recall Terminated

    VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN #M001454510, Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains catheter, cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; StatLock Catheter Securement Device, Instructions for Use; Peelaway Sheath Introducer; 10 mL Syringe; CSR Wrap.

    Recall: Z-0404-05 · Initiated November 22, 2004

    Recall

    Recall Number
    Z-0404-05
    Event Number
    30572
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 22, 2004
    Posted
    January 20, 2005
    Terminated
    December 16, 2005
    Address
    1 Boston Scientific Pl, Natick, MA, 01760-1536

    Description

    VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN #M001454510, Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains catheter, cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; StatLock Catheter Securement Device, Instructions for Use; Peelaway Sheath Introducer; 10 mL Syringe; CSR Wrap.

    Reason

    Catheter separation immediately distal to the nose of the suture wing.

    Action

    Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.

    Distribution

    75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.

    Quantity

    167 kits