BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1184-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1184-2020
    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-WH

    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: 13F18L0892 13F19C0478 13F19E0433 13F19K0051 13F19B0588 13F19D0327 13F19H0209 13F19L0079

    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