BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A

    Recall: Z-2435-2024 · Reported July 31, 2024

    Enforcement

    Recall Number
    Z-2435-2024
    Event ID
    94890
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B Braun Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2024
    Initiation Date
    June 14, 2024
    Classification Date
    July 25, 2024
    Address
    200 Boulder Dr, Breinigsville, PA, 18031-1532, United States

    Description

    Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A

    Reason

    Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.

    Code Info

    Lot Code: Model No 8713080U; UDI-DI 4046963915308; All Serial Numbers

    Distribution

    Domestic distribution nationwide. International distribution to Canada.

    Quantity

    1663