BEUDAMED
    FDA Enforcement Class III Terminated

    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970535, Catalog No.REF 06597053, 3) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970555, Catalog No.REF 06597055 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

    Recall: Z-0775-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0775-2017
    Event ID
    75420
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    September 28, 2016
    Classification Date
    December 16, 2016
    Termination Date
    June 18, 2018
    Address
    603 Queensbury Ave, N/A, Queensbury, NY, 12804-7619, United States

    Description

    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970535, Catalog No.REF 06597053, 3) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970555, Catalog No.REF 06597055 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

    Reason

    Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.

    Code Info

    Batch/Lot: 1) 5030537, 5037976, 5043444, 5059984, 5066413, 2) 5024545, 5031723, 5038659, 5042534, 5065538, 5071294, 5076428, 5082169, 3) 5022318, 5032456, 5034279, 5081986, 5082446

    Distribution

    Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX

    Quantity

    996 boxes