BEUDAMED
    FDA Enforcement Class II Terminated

    Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model GTIN-14 11827 Prometra Programmable 20mL Pump 00810335020082 13827 Prometra II Programmable 20mLPump 00810335020228 16827 Prometra II Programmable 40mLPump 00810335020242

    Recall: Z-1996-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1996-2021
    Event ID
    88044
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Flowonix Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 7, 2021
    Initiation Date
    May 26, 2021
    Classification Date
    July 1, 2021
    Termination Date
    February 20, 2024
    Address
    120 Forbes Blvd Ste 170, N/A, Mansfield, MA, 02048-1150, United States

    Description

    Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model GTIN-14 11827 Prometra Programmable 20mL Pump 00810335020082 13827 Prometra II Programmable 20mLPump 00810335020228 16827 Prometra II Programmable 40mLPump 00810335020242

    Reason

    Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as 'reuse the same drug solution extracted from the pump prior to the MRI procedure', creating a possible risk of infection

    Code Info

    All Physician Order Form (PL-15400-00, Nov. 2018)

    Distribution

    US Nationwide distribution.

    Quantity

    N/A