Z-0028-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2012
- Initiation Date
- August 29, 2012
- Termination Date
- January 15, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 800 needles
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.
Reason for Recall
Sterility of the product may be compromised.
Distribution Pattern
Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.
Code Information
NAC-1820M, Lot number: 121003