BEUDAMED
    FDA Recall Open, Classified

    Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEART MHS, Model Number DYNJ905394B, g. OPEN HEART WPH, Model Number DYNJ908168 Model/Catalog Number: Model Numbers: a. CDS984642, b. DYNJ902880J, c. DYNJ902880K, d. DYNJ904831F, e. DYNJ905394A, f. DYNJ905394B, g. DYNJ908168 Product Description: convenience kits labeled as follows:

    Recall: Z-1470-2022 · Initiated June 6, 2022

    Recall

    Recall Number
    Z-1470-2022
    Event Number
    90516
    Firm
    MEDLINE INDUSTRIES, LP SPT
    FEI Number
    3000717925
    Product Code
    OEZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 6, 2022
    Address
    1170 S Northpoint Blvd, Waukegan, IL, 60085-6757

    Description

    Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEART MHS, Model Number DYNJ905394B, g. OPEN HEART WPH, Model Number DYNJ908168 Model/Catalog Number: Model Numbers: a. CDS984642, b. DYNJ902880J, c. DYNJ902880K, d. DYNJ904831F, e. DYNJ905394A, f. DYNJ905394B, g. DYNJ908168 Product Description: convenience kits labeled as follows:

    Reason

    Kits contain leaking bottles of isopropyl alcohol

    Action

    The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations.

    Distribution

    US Nationwide distribution.

    Quantity

    1960