BEUDAMED
    FDA Recall Open, Classified

    Perifix / Epidural anesthesia set, medicated

    Recall: Z-2627-2023 · Initiated July 31, 2023

    Recall

    Recall Number
    Z-2627-2023
    Event Number
    92913
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    OGE
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    July 31, 2023
    Posted
    September 21, 2023
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    Perifix / Epidural anesthesia set, medicated

    Reason

    Product may be mislabeled with an incorrect lid stock label.

    Action

    An "URGENT MEDICAL DEVICE RECALL" letter dated 8/14/23 was issued to affected customers on 08/14/2023. The letter described the product, problem and actions to be taken. The Customers are instructed to review inventory, cease use and quarantine impacted product and complete and return the Product Recall Acknowledgement Form back to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610)849-1197 or email to [email protected]. B. Braun Medical will facilitate return of impacted product. If you have any questions, contact BBMI's Postmarket Surveillance Department at 1-833-425-1464.

    Distribution

    US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, WA

    Quantity

    3440 units