Automatic Cutting Needles, Soft Tissue Biopsy Needle… recallZ-0028-2013 · Remington Medical Inc. · initiated Aug 29, 2012
Class II Terminated All recalls posted in October 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remington Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterility of the product may be compromised.
FDA root cause category: Material/Component Contamination
What the company is doing
The firm, Remington Medical, Inc., sent an "URGENT - MEDICAL DEVICE RECALL" letter dated August 29, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the products; complete and return the FaxBack form via Fax to: Quality Engineer Remington Medical, Inc., at 770-887-0732 or email: [email protected]; and call the Quality Engineer or customer service at (800) 989-0057 ext 233 to obtain a RGA number and have a call tag issued. Should you have any questions, please do not hesitate to call the Quality Engineer at (800) 989-0057 ext 233.
Recall details
- Recall number
- Z-0028-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 29, 2012
- Posted by the FDA
- Oct 9, 2012
- Recalling firm
- Remington Medical Inc.
- Quantity
- 800 needles
- Product code
- KNW
- FDA submissions
- K982401
- 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.
Code information (models, lots, serial numbers)
NAC-1820M, Lot number: 121003
Other devices under the same FDA submission
1 device cleared under K982401 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Automatic Cutting Needle NAC-1820MRemington Medical, Inc. · INSTRUMENT, BIOPSY1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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