BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046H; Medical procedure convenience tray

    Recall: Z-1918-2024 · Reported June 5, 2024

    Enforcement

    Recall Number
    Z-1918-2024
    Event ID
    94448
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 5, 2024
    Initiation Date
    March 1, 2024
    Classification Date
    May 29, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046H; Medical procedure convenience tray

    Reason

    Trumpet Needle Guide ring can detach when excessive pressure is applied.

    Code Info

    a) DYNDH1832: UDI/DI 40195327330713 (case), 10195327330712 (unit), Lot Numbers: 23KBI682, 23KBT359, 23KBX629; b) DYNJRA2210: UDI/DI 40195327424047 (case), 10195327424046 (unit), Lot Numbers: 23JBX245, 23LBN930; c) DYNJRA9046: UDI/DI 40195327338610 (case), 10195327338619 (unit), Lot Numbers: 23JBX367, 23JBX368, 23JBX369, 23JBX370, 23LBA896, 23LBH751, 23LBL612, 23LBV325, 23LBV326; d) DYNJRA9046H: UDI/DI 40195327338610 (case), 10195327338619 (unit), Lot Numbers: 23JBX367, 23LBL612, 23LBV325;

    Distribution

    US Nationwide distribution.

    Quantity

    12994 units