BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated March 1, 2024

    Recall

    Recall Number
    Z-1918-2024
    Event Number
    94448
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    OJH
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 1, 2024
    Posted
    May 29, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    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.

    Action

    Medline issued a correction notice to its consignees on 03/01/2024 via email and USPS first class mail. The notice explained the issue and requested the consignee identify and quarantine all affected products, and respond to the notice. Once the response was received Medline would provide labels to place over the affected product in stock. If the product was further distributed the party which distributed the product was directed to notify their customers.

    Distribution

    US Nationwide distribution.

    Quantity

    12994 units