FDAFDA · Food and drugs·Recall number Z-0028-2013
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.
Published October 17, 2012 · Recall initiated: August 29, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility of the product may be compromised.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remington Medical Inc.
- Distributor
- Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.
- Lot
- NAC-1820M, Lot number: 121003
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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