BEUDAMED
    FDA Enforcement Class II Terminated

    5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST

    Recall: Z-1889-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1889-2018
    Event ID
    79801
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon Endo-Surgery Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 23, 2018
    Initiation Date
    March 26, 2018
    Classification Date
    May 15, 2018
    Termination Date
    April 8, 2020
    Address
    4545 Creek Rd, Blue Ash, OH, 45242-2803, United States

    Description

    5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST

    Reason

    Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.

    Code Info

    Lots P4T686 P4T79A P4T99K P4TC30 P4TD2D R40191 R40223 R4045J R4054D R40642

    Distribution

    Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.

    Quantity

    11074