BEUDAMED
    FDA Enforcement Class I Terminated

    Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.

    Recall: Z-0085-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0085-2014
    Event ID
    66368
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baylis Medical Corp *
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2013
    Initiation Date
    September 23, 2013
    Classification Date
    November 1, 2013
    Termination Date
    March 31, 2015
    Address
    5959 TransCanada Highway, N/A, Montreal, N/A, N/A, Canada

    Description

    Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.

    Reason

    The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream.

    Code Info

    Part No. TF8-32-63-135, Lot TFFB070912; Part No.TF8-32-63-37, Lot TFFA310812; Part. No. TF8-32-63-37, Lot TFFB290113; Part No. TF8-32-63-45, Lot TFFA290113; Part No. TF8-32-63-45, Lot TFFB310812; Part No. TF8-32-63-45, Lot TFFC221211; Part No. TF8-32-63-55, Lot TFFA051212; Part No. TF8-32-63-55, Lot TFFA230812; Part No. TF8-32-63-55, Lot TFFB221211; Part No. TF8-32-63-55, Lot TFFB230113; Part No. TF8-32-63-90, Lot TFFA070213; Part No. TF8-32-63-90, Lot TFFA070912; Part No. TF8-32-81-135, Lot TFFH070912; Part No. TF8-32-81-37, Lot TFFD070912; Part No. TF8-32-81-45, Lot TFFE070912; Part No. TF8-32-81-55, Lot TFFF070912; Part No. TF8-32-81-90, Lot TFFG070912; Part No. TF8-38-62-S, Lot TFFA201212; Part No. TF85-32-63-37, Lot TFFC070912; Part No. TF85-32-63-45, Lot TFFA221211; Part No. TF85-32-63-45, Lot TFFA250512; Part No. TF85-32-63-45, Lot TFFC051212; Part No. TF85-32-63-45, Lot TFFC230812; Part No. TF85-32-63-55, Lot TFFA230113; Part No. TF85-32-63-55, Lot TFFA290812; Part No. TF85-32-63-55, Lot TFFB070612; Part No. TF85-32-63-90, Lot TFFB230812; Part No. TF85-32-63-90, Lot TFFC260413; Part No. TF85-32-63-90, Lot TFFC280213; Part No. TF85-32-63-90, Lot TFFF070213; Part No. TF85-32-81-135, Lot TFFC280912; Part No. TF85-32-81-37, Lot TFFA280912; and Part No. TF85-32-81-90, Lot TFFB280912

    Distribution

    Worldwide Distribution - USA Nationwide in the states of : NE, NH, NC, FL, PA, VA, MI, CA, AL, and TN and the countries of China, Canada, Saudi Arabia, and Italy.

    Quantity

    370 devices