BEUDAMED
    FDA Enforcement Class I Ongoing

    Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case

    Recall: Z-2007-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2007-2026
    Event ID
    98698
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medical Action Industries, Inc. 306
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2026
    Initiation Date
    March 17, 2026
    Classification Date
    May 6, 2026
    Address
    25 Heywood Rd, Arden, NC, 28704-9302, United States

    Description

    Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case

    Reason

    Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"

    Code Info

    UDI:20809160490294/ Lot numbers: 342509, 346066, 338434, 339423, 337365, 335489, 336189, 336789

    Distribution

    US distribution to state of: AZ OUS: None

    Quantity

    2030 kits