BEUDAMED
    FDA Enforcement Class II Terminated

    FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1

    Recall: Z-1183-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1183-2020
    Event ID
    84726
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2020
    Initiation Date
    January 15, 2020
    Classification Date
    February 13, 2020
    Termination Date
    March 17, 2023
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1

    Reason

    There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.

    Code Info

    Lots: 23F19A0154 23F19C0273 23F19F0029 23F19G0360 23F19M0226

    Distribution

    The products were distributed to the following US states: AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.

    Quantity

    343,105 total