BEUDAMED
    FDA Enforcement Class II Terminated

    A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.

    Recall: Z-2098-2019 · Reported August 7, 2019

    Enforcement

    Recall Number
    Z-2098-2019
    Event ID
    83285
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alto Development Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 7, 2019
    Initiation Date
    June 21, 2019
    Classification Date
    July 29, 2019
    Termination Date
    May 13, 2020
    Address
    5206 Asbury Rd, N/A, Wall Township, NJ, 07727-3609, United States

    Description

    A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.

    Reason

    Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.

    Code Info

    Lots 0715A or later

    Distribution

    Distribution US Nationwide, Czech Republic, Italy, Israel, and UK.

    Quantity

    351.5 Boxes