Recall Z-0028-2013— Remington Medical Inc.
Class II · Terminated
Class II FDA medical device recall by Remington Medical Inc., initiated 2012-08-29, terminated 2013-01-15. It names one FDA 510(k) clearance: K982401. 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.. Reason: Sterility of the product may be compromised..
- Recalling firm
- Remington Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-29
- Terminated
- 2013-01-15
- Firm location
- Alpharetta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.