BEUDAMED
    FDA Recall Terminated

    ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

    Recall: Z-1029-2016 · Initiated February 17, 2016

    Recall

    Recall Number
    Z-1029-2016
    Event Number
    73376
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    DRE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 17, 2016
    Posted
    March 1, 2016
    Terminated
    March 8, 2017
    Address
    1445 Flat Creek Rd, Athens, TX, 75751-5002

    Description

    ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

    Reason

    The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.

    Action

    On February 17, a letter was sent to Medtronic notifying them of a voluntary recall.

    Distribution

    Distributed in IL.

    Quantity

    2000 units