BEUDAMED
    FDA Enforcement Class II Terminated

    (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.

    Recall: Z-1228-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1228-2022
    Event ID
    89530
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BSN Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 15, 2022
    Initiation Date
    February 1, 2022
    Classification Date
    June 3, 2022
    Termination Date
    August 9, 2023
    Address
    5825 Carnegie Blvd, Charlotte, NC, 28209-4633, United States

    Description

    (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.

    Reason

    The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.

    Code Info

    Lot #127384, Exp. 2024-02-10 UDI for JOBST Compri2 - (01)04042809506648(20)01(17)240210(10)127384; UDI for JOBST Compri2 lite - (01)04042809506631

    Distribution

    US Nationwide distribution in the states of AZ, FL, CA, IL, KS, MA, MN, MO, NC, NH, OH, PA, TX, VA, and WA. There was no foreign/government/military distribution.

    Quantity

    1,677