BEUDAMED
    FDA Recall Terminated

    SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20

    Recall: Z-2277-2019 · Initiated June 3, 2019

    Recall

    Recall Number
    Z-2277-2019
    Event Number
    83070
    Firm
    Suntech Medical, Inc.
    FEI Number
    1036863
    Product Code
    DXQ
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    June 3, 2019
    Terminated
    December 16, 2020
    Address
    507 Airport Blvd, Ste 117, Morrisville, NC, 27560-8200

    Description

    SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20

    Reason

    Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.

    Action

    On June 3, 2019, SunTech Medical sent an Urgent Medical Device Customer Notification to their one consignees advising them of the issue and requesting that they completed the enclosed Recall Acknowledgement Form. This letter further request this consignee to conduct a sub-recall by using the provided Customer Template Letter and Recall Acknowledgement Template.

    Distribution

    Pakistan

    Quantity

    80 total cuffs affected; 4 Boxes of 20 cuffs