BEUDAMED
    FDA Enforcement Class II Terminated

    Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.

    Recall: Z-2140-2021 · Reported August 4, 2021

    Enforcement

    Recall Number
    Z-2140-2021
    Event ID
    88285
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Medical Systems USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 4, 2021
    Initiation Date
    July 14, 2021
    Classification Date
    July 23, 2021
    Termination Date
    August 3, 2022
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.

    Reason

    There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.

    Code Info

    HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected.

    Distribution

    Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.

    Quantity

    33