BEUDAMED
    FDA Enforcement Class II Ongoing

    BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system. Catalog Number: 515304

    Recall: Z-1555-2022 · Reported August 24, 2022

    Enforcement

    Recall Number
    Z-1555-2022
    Event ID
    90567
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2022
    Initiation Date
    July 18, 2022
    Classification Date
    August 18, 2022
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system. Catalog Number: 515304

    Reason

    Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.

    Code Info

    UDI-DI: 30382905153045 Lot Numbers: 2007212, 2103205

    Distribution

    US Nationwide Distribution CA FL GA IL MD MI OR PA PR TN TX

    Quantity

    9,340 units