BEUDAMED
    FDA Recall Open, Classified

    Perifix / Epidural anesthesia kit (10 count carton)

    Recall: Z-2002-2023 · Initiated June 5, 2023

    Recall

    Recall Number
    Z-2002-2023
    Event Number
    92523
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    OGE
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    June 5, 2023
    Posted
    June 23, 2023
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    Perifix / Epidural anesthesia kit (10 count carton)

    Reason

    Kits were assembled with the incorrect Filter Straw.

    Action

    Customers received a recall notification dated 06/05/2023 by mail notifying them that affected lots of Epidural Kits were inadvertently assembled with the incorrect Filter Straw. The recall notification asks customers to determine if any affected devices are in inventory and subsequently quarantine any identified product, return the Product Recall Acknowledgement Form notating any affected devices currently in quarantine, and return the form by fax to 610-849-1197 or by email to [email protected]. Coordination of product return for provision of credit/replacement will commence upon return of the form. If product has been further distributed the firm asks that the recall notification be forwarded to those consignees down to the consumer level. Customers with any questions can direct them to BBMI's Postmarket Surveillance Department at 1-883-425-1464.

    Distribution

    US Nationwide distribution.

    Quantity

    16,070 units