BEUDAMED
    FDA Recall Terminated

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY

    Recall: Z-0216-2018 · Initiated June 7, 2017

    Recall

    Recall Number
    Z-0216-2018
    Event Number
    77661
    Firm
    Terumo Medical Corp
    FEI Number
    2243441
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 7, 2017
    Terminated
    April 25, 2019
    Address
    2101 Cottontail Ln, Somerset, NJ, 08873-1277

    Description

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, 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.

    Action

    URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters (dated June 7, 2017) and Response Forms were sent to the consignees via UPS on June 7, 2017.

    Distribution

    Nationwide and Canada