BEUDAMED
    FDA Enforcement Class II Ongoing

    (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.

    Recall: Z-0533-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0533-2025
    Event ID
    95638
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    October 15, 2024
    Classification Date
    November 25, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.

    Reason

    Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

    Code Info

    (1) REF DYNJ59194A - Lot numbers 24DLA916, exp. 12/31/2025; and 24BLA030, exp. 11/30/2025; UDI-DI each 10193489573480, UDI-DI case 40193489573481; and (2) REF DYNJ904220F - Lot number 24DLA070, exp. 11/30/2024, UDI-DI each 10195327362300, UDI-DI case 40195327362301.

    Distribution

    US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.

    Quantity

    360 kits