BEUDAMED
    FDA Enforcement Class II Terminated

    Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.

    Recall: Z-0028-2013 · Reported October 17, 2012

    Enforcement

    Recall Number
    Z-0028-2013
    Event ID
    63070
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remington Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2012
    Initiation Date
    August 29, 2012
    Classification Date
    October 9, 2012
    Termination Date
    January 15, 2013
    Address
    6830 Meadowridge Ct., N/A, Alpharetta, GA, 30005, United States

    Description

    Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.

    Reason

    Sterility of the product may be compromised.

    Code Info

    NAC-1820M, Lot number: 121003

    Distribution

    Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.

    Quantity

    800 needles