BEUDAMED
    FDA Enforcement Class II Terminated

    CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft.

    Recall: Z-1642-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1642-2018
    Event ID
    79811
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiopulmonary Ag
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    April 4, 2018
    Classification Date
    May 4, 2018
    Termination Date
    March 29, 2019
    Address
    Kehler Strasse 31, N/A, Rastatt, N/A, N/A, Germany

    Description

    CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft.

    Reason

    There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.

    Code Info

    US: 98880-020 Foreign: 98880 - 002, 98880 - 004, 98880 - 005, 98880 - 006, 98880-009, 98880-010, 98880-011, 98880-012, 98880- 013, 98880-014, 98880-016, 98880-017, 98880-018

    Distribution

    The product was distributed to the following US state: MO. The product was distributed to the following foreign countries: France, Germany, Switzerland, and Thailand.

    Quantity

    14 units (1 US, 13 International)