BEUDAMED
    FDA Recall Terminated

    Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR Bard 10636-010 8005022 Kit Coax 10 Pack 5FR Bard The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.

    Recall: Z-1614-2014 · Initiated April 28, 2014

    Recall

    Recall Number
    Z-1614-2014
    Event Number
    68161
    Firm
    Greatbatch Medical
    FEI Number
    2183787
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    April 28, 2014
    Posted
    May 13, 2014
    Terminated
    May 24, 2016
    Address
    2300 Berkshire Ln N, Minneapolis, MN, 55441-4575

    Description

    Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR Bard 10636-010 8005022 Kit Coax 10 Pack 5FR Bard The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.

    Reason

    Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.

    Action

    Greatbatch sent an "Urgent Medical Device Recall" letter dated April 25, 2014 to affected customers via email and Fedex. The letter described the Reason for Recall, Risk to Health, and Instructions to Customers. Requested consignees to immediately place affected devices in quarantine and to complete and return the Field Correction Action Response Form. For questions they should contact their local Greatbatch representative or 1-763-951-8235, or e-mail [email protected].

    Distribution

    US Nationwide Distribution in the state of UT.

    Quantity

    6,642 sets (66,420 devices)