BEUDAMED
    FDA Enforcement Class II Terminated

    ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit

    Recall: Z-0114-2015 · Reported October 29, 2014

    Enforcement

    Recall Number
    Z-0114-2015
    Event ID
    69256
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 29, 2014
    Initiation Date
    September 15, 2014
    Classification Date
    October 22, 2014
    Termination Date
    December 18, 2015
    Address
    2400 Bernville Road, Reading, PA, 19605, United States

    Description

    ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit

    Reason

    Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syringe, 10mL, Luer-Slip Loss of Resistance, Glass but contains one Syringe, 10mL, Luer-Lock Loss of Resistance, Glass.

    Code Info

    Catalog No. ASK-05501-AFH1 Lot Number 23F13K0969

    Distribution

    US Distribution in Utah only.

    Quantity

    300