BEUDAMED
    FDA Recall Terminated

    Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator; And One (1) B* x 135 cm Guidewire. Intended to allow left heart catheterization procedure to occur through the right atrium.

    Recall: Z-0816-2010 · Initiated February 8, 2010

    Recall

    Recall Number
    Z-0816-2010
    Event Number
    54526
    Firm
    Baylis Medical Corp
    FEI Number
    3005241199
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 8, 2010
    Posted
    March 10, 2010
    Terminated
    September 13, 2010
    Address
    5959 Trans-Canada Hwy, Montreal Canada

    Description

    Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator; And One (1) B* x 135 cm Guidewire. Intended to allow left heart catheterization procedure to occur through the right atrium.

    Reason

    Radiopaque soft tip may fracture.

    Action

    Baylis Medical Issued an "Urgent Medical Device Correction" letter via overnight courier beginning February 8, 2010. Consignees were instructed to segregate and return all affected product to the firm. For further information, contact Baylis Medical Regulatory Scientific Affairs at 1-905-602-4875 Extension 252.

    Distribution

    Worldwide Distribution -- United States, Canada, Chile, China, Colombia, Denmark, Egypt, France, Germany, Hong Kong, Italy, Mexico, Netherlands, New Zealand, Portugal, Qatar, Russia, Singapore, South Africa, Sweden, Switzerland, United Arab Emirates and the United Kingdom.

    Quantity

    1,085 units (508 in US, 577 Foreign)