Devices

Device Recall Automatic Cutting Needles

  • Model / Serial
    NAC-1820M, Lot number: 121003
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.
  • Product 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.
  • Manufacturer
    Remington Medical Inc.
  • 1 Event

Manufacturer

Remington Medical Inc.
  • Manufacturer Address
    Remington Medical Inc., 6830 Meadowridge Ct., Alpharetta GA 30005
  • Manufacturer Parent Company (2017)
    Remington Medical, Inc.
  • Source
    USFDA