BEUDAMED
    FDA Enforcement Class II Terminated

    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY

    Recall: Z-0221-2018 · Reported December 20, 2017

    Enforcement

    Recall Number
    Z-0221-2018
    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 - 16CM (0.021), REF/Product Code RM*ES6F16HAU, 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 s 161209, 170118, 170215, 170317

    Distribution

    Nationwide and Canada

    Quantity

    N/A