BEUDAMED
    FDA Enforcement Class II Ongoing

    McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)

    Recall: Z-2940-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2940-2024
    Event ID
    95041
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cypress Medical Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2024
    Initiation Date
    July 24, 2024
    Classification Date
    August 29, 2024
    Address
    9954 Mayland Dr, Richmond, VA, 23233-1464, United States

    Description

    McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)

    Reason

    Affected syringes lack FDA clearance.

    Code Info

    All lots of the affected product 102-S60C, SYRINGE, LL 60CC which are within their expiration date, are being recalled. Products were manufactured within the last five years. Affected lots: All lots beginning with alpha characters CLN. UDI-DI (01)30612479170316

    Distribution

    US distribution only. Domestic distribution nationwide.

    Quantity

    24,693,200 eaches (US)