BEUDAMED
    FDA Enforcement Class II Ongoing

    Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels

    Recall: Z-2779-2017 · Reported August 9, 2017

    Enforcement

    Recall Number
    Z-2779-2017
    Event ID
    77508
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Myelotec, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 9, 2017
    Initiation Date
    March 2, 2017
    Classification Date
    July 28, 2017
    Address
    4000 Northfield Way Ste 900, N/A, Roswell, GA, 30076-4955, United States

    Description

    Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels

    Reason

    Obstructed/blocked port from defective VGC Access Port Body component.

    Code Info

    Lot No. 4123/MY33613, 4250/MY06614, 4279/MY06614, 4305/MY10814, 4331/MY13914, and 4331/MY25214

    Distribution

    Worldwide Distribution - US Distribution to the states of : CA, FL, KY, MN, and NJ ., and to the countries of : Brazil, Iran, Kuwait, Malaysia, Singapore, South Korea, Taiwan, and Turkey

    Quantity

    2980 units