BEUDAMED
    FDA Enforcement Class II Terminated

    NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire

    Recall: Z-1344-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1344-2016
    Event ID
    72957
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AngioDynamics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2016
    Initiation Date
    November 3, 2015
    Classification Date
    April 7, 2016
    Termination Date
    March 16, 2017
    Address
    10 Glens Falls Tech Park, N/A, Glens Falls, NY, 12801-3864, United States

    Description

    NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire

    Reason

    Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036".

    Code Info

    Batch/Lot No. 4925152, 4930012; Use By 2018-08

    Distribution

    US Nationwide in the states of CA, IL, MA, SC, TX

    Quantity

    100 kits