BEUDAMED
    FDA Enforcement Class III Ongoing

    AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.

    Recall: Z-2781-2020 · Reported August 19, 2020

    Enforcement

    Recall Number
    Z-2781-2020
    Event ID
    85094
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Linet Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 19, 2020
    Initiation Date
    March 6, 2020
    Classification Date
    August 12, 2020
    Address
    10420 Harris Oak Blvd, N/A, Charlotte, NC, 28269-7517, United States

    Description

    AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.

    Reason

    The UDI on the device label indicates incorrect manufacturer.

    Code Info

    Model Number 4BCPPB-3XCZ0002 (Lot Numbers PPB1155 - PPB1174, PPB1194 - PPB1213, PPB1222 - PPB1241, PPB1265 - PPB1284, PPB1292 - PPB1311, PPB1346 - PPB1365, PPB1375 - PPB1394, PPB1451 - PPB1466, PPB1477 - PPB1496, PPB1508 - PPB1527); Model Number 4BCPPB-CCZ0008, Lot Number PPB1446 - PPB1449; Model Number 4BCPPB-BCZ0009, Lot Number PPB1541 - PPB1542

    Distribution

    US Nationwide distribution including in the states of Arkansas, California, Delaware, Florida, Georgia, Indiana, Louisiana, Massachusetts, Minnesota, Mississippi, Missouri, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia and Puerto Rico.

    Quantity

    202 devices