BEUDAMED
    FDA Enforcement Class II Terminated

    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY

    Recall: Z-0220-2018 · Reported December 20, 2017

    Enforcement

    Recall Number
    Z-0220-2018
    Event ID
    77661
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Medical Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2017
    Initiation Date
    June 7, 2017
    Classification Date
    December 8, 2017
    Termination Date
    April 25, 2019
    Address
    2101 Cottontail Ln, N/A, Somerset, NJ, 08873-1277, United States

    Description

    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY

    Reason

    An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

    Code Info

    Lot s161019, 161102, 161103, 161118, 161201, 161202, 161205, 161215, 161216, 170109, 170110, 170111, 170202, 17023

    Distribution

    Nationwide and Canada

    Quantity

    N/A