BEUDAMED
    FDA Recall Terminated

    Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.

    Recall: Z-0760-2019 · Initiated September 6, 2018

    Recall

    Recall Number
    Z-0760-2019
    Event Number
    81755
    Firm
    Stihler Electronic Gmbh Julius-Holder-Str. 36 Stuttgart Germany
    FEI Number
    3001733054
    Product Code
    KOC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 6, 2018
    Terminated
    May 13, 2020

    Description

    Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 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

    Action

    STIHLER ELECTRONIC GMBH notified distributors by Registered mail/email and to Head of Biomedical on 09/06/18 identifying the problem, health risk and action to be taken: identify the Heating Profiles according to the serial numbers specified. These profiles must be replaced based on your accurate reply. Complete Inventory must be accounted for. For your reply use attached "Return Form" to Stihler Electronic GmbH. Send the filled return form via e-mail to nicola. vosseler@sti hlerelectronic. de. 3. You will receive the replacement Heating Profiles from our distributor Futuremed America Inc., 15700 Devonshire Street, Granada Hills, 91344 California, US.

    Distribution

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

    Quantity

    1 unit