BEUDAMED
    FDA Enforcement Class II Terminated

    Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91

    Recall: Z-1779-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1779-2022
    Event ID
    90834
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SunMed Holdings, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 5, 2022
    Initiation Date
    September 8, 2022
    Classification Date
    September 23, 2022
    Termination Date
    June 18, 2024
    Address
    2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, 49544-9112, United States

    Description

    Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91

    Reason

    The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.

    Code Info

    UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11

    Distribution

    Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.

    Quantity

    53,560 units