BEUDAMED
    FDA Enforcement Class II Terminated

    20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

    Recall: Z-0051-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0051-2020
    Event ID
    83650
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Repro-Med Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2019
    Initiation Date
    August 20, 2019
    Classification Date
    October 7, 2019
    Termination Date
    May 29, 2020
    Address
    24 Carpenter Rd, N/A, Chester, NY, 10918-1057, United States

    Description

    20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

    Reason

    Mislabeled needle lengths

    Code Info

    Lot # N.78648 GTIN: 00659443000292

    Distribution

    US Nationwide distribution including the states of NJ, OH, FL, GA, IL, MA, CA, TX, NC, IA, NV, OR, MD, TN, VA, NY.

    Quantity

    1990 pouches