BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A

    Recall: Z-1466-2026 · Reported March 4, 2026

    Enforcement

    Recall Number
    Z-1466-2026
    Event ID
    98333
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2026
    Initiation Date
    January 8, 2026
    Classification Date
    February 24, 2026
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A

    Reason

    Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

    Code Info

    SKU DYNDA2705 UDI-DI (ea) 10193489468632 UDI-DI (case) 40193489468633 Kit lots 24DBL787 24HBR630 25ABH699 25DBV209 25GBQ405 SKU DYNJ63347A UDI-DI (ea) 10193489278064 UDI-DI (case) 40193489278065 Kit lots 24AMC874 24AME139 24AMH820 24BMF097 24CMF691 24GMB769 24GMK036 24IMC124 24LMA110 25AMJ634 25GMD386 25IMB510 25JMI708

    Distribution

    US Nationwide distribution.

    Quantity

    1212