BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Component: N/A

    Recall: Z-2434-2024 · Initiated June 14, 2024

    Recall

    Recall Number
    Z-2434-2024
    Event Number
    94890
    Firm
    B Braun Medical Inc
    FEI Number
    3003218564
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 14, 2024
    Posted
    July 25, 2024
    Address
    200 Boulder Dr, Breinigsville, PA, 18031-1532

    Description

    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U 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.

    Action

    On June 14, 2024, the firm notified customers via URGENT MEDICAL DEVICE FIELD CORRECTION NOTIFICATION letters. Customers were advised to not use the recalled syringes in Perfusor Space Syringe Pumps. All users should be informed of the correction. Customers were provided with an attachment to post in care areas as a reminder to not use the recalled syringes with the specified pumps.

    Distribution

    Domestic distribution nationwide. International distribution to Canada.

    Quantity

    9943