BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2779-2017 · Initiated March 2, 2017

    Recall

    Recall Number
    Z-2779-2017
    Event Number
    77508
    Firm
    Myelotec, Inc.
    FEI Number
    3000215691
    Product Code
    HRX
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 2, 2017
    Address
    4000 Northfield Way, Ste 900, Roswell, GA, 30076-4955

    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.

    Action

    Myelotec sent an Urgent Product Recall Notification letter dated April 10, 2017, to all affected customers. Customers are instructed to notify customers of any product further distributed, identify any recalled product on hand, and to complete the attached recall response, to be sent back to the distributor. For further questions, please call (770) 664-4656 Ext. 140.

    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