BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1779-2022 · Initiated September 8, 2022

    Recall

    Recall Number
    Z-1779-2022
    Event Number
    90834
    Firm
    SunMed Holdings, LLC
    FEI Number
    1314417
    Product Code
    CBT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 8, 2022
    Posted
    September 23, 2022
    Terminated
    June 18, 2024
    Address
    2710 Northridge Dr Nw, Ste A, Grand Rapids, MI, 49544-9112

    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.

    Action

    On September 8, 2022, the firm sent Urgent Medical Device Product Removal letters via email to affected customers. Customers were instructed to either return or destroy and discard affected product. If customers have further distributed the affected device, they should forward the notification to the receiving facility. Sun Med will provide new replacement product. If you have any questions regarding this field action, please call SunMed at 1-800-433-2797, or e-mail at [email protected].

    Distribution

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

    Quantity

    53,560 units