Device product
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.
Z-0028-2013
Product summary
- Event
- Event 63070
- Status
- Terminated
- Classification
- Class II
- Quantity
- 800 needles
- Official record key
device-enforcement:Z-0028-2013
Official wording
Reason: Sterility of the product may be compromised.
Code information: NAC-1820M, Lot number: 121003
Distribution pattern: Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.
Derived failure modes
-
Unknown
Sterility of the product may be compromised.