BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2277-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2277-2019
    Event ID
    83070
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Suntech Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2019
    Initiation Date
    June 3, 2019
    Classification Date
    August 14, 2019
    Termination Date
    December 16, 2020
    Address
    507 Airport Blvd Ste 117, N/A, Morrisville, NC, 27560-8200, United States

    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.

    Code Info

    Catalog # 98-0400-98 Lot Number: A4H201

    Distribution

    Pakistan

    Quantity

    80 total cuffs affected; 4 Boxes of 20 cuffs