BEUDAMED
    FDA Recall Terminated

    CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray, PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX FX Continuous Epidural Tray, PERIFIX One Continuous Epidural Pediatric Tray; Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Route of administration is injection into subarachnoid space or epidural space or tissue surrounding peripheral nerve bundle(s). Custom Epidural and Anesthesia Tray

    Recall: Z-1576-2015 · Initiated March 27, 2015

    Recall

    Recall Number
    Z-1576-2015
    Event Number
    70870
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    BRY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 27, 2015
    Posted
    May 4, 2015
    Terminated
    February 1, 2017
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray, PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX FX Continuous Epidural Tray, PERIFIX One Continuous Epidural Pediatric Tray; Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Route of administration is injection into subarachnoid space or epidural space or tissue surrounding peripheral nerve bundle(s). Custom Epidural and Anesthesia Tray

    Reason

    There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contamination of the spinal fluid or epidural space.

    Action

    BBMI provided a recall notification letter, dated March 27, 2015, to distributors and end users in receipt of suspect product, along with acknowledgement forms detailing the suspect product that was distributed to each account. All customers were provided with instructions for disposition of suspect product in their inventory. Distributors were reminded of their responsibility in executing the recall. Returned product will be sent to the BBMI Distribution Center in Breiningsville, PA.

    Distribution

    Nationwide Distribution.

    Quantity

    5000