BEUDAMED
    FDA Enforcement Class II Terminated

    Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.

    Recall: Z-0759-2019 · Reported January 30, 2019

    Enforcement

    Recall Number
    Z-0759-2019
    Event ID
    81755
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stihler Electronic Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 30, 2019
    Initiation Date
    September 6, 2018
    Classification Date
    January 23, 2019
    Termination Date
    May 13, 2020
    Address
    Julius-Holder-Str. 36, N/A, Stuttgart, N/A, N/A, Germany

    Description

    Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.

    Reason

    PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn

    Code Info

    Serial Numbers: E22000 to E23999

    Distribution

    Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland

    Quantity

    821