Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25… recallZ-0673-2007 · Remington Medical Inc. · initiated Jan 19, 2007
Terminated All recalls posted in March 2007
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
Pouches were not sealed prior to sterilization.
FDA root cause category: Other
What the company is doing
Consignees were contacted by telephone on 01/19/2007. Each customer was informed the sterility of the product may be compromised as a result of unsealed pouches and requested to visually check their inventory.
Recall details
- Recall number
- Z-0673-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 19, 2007
- Posted by the FDA
- Mar 29, 2007
- Recalling firm
- Remington Medical Inc.
- Quantity
- 192 units
- Product code
- KNW
- FDA submissions
- K982401
- Distribution
- Nationwide.
Product description
Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.
Code information (models, lots, serial numbers)
Lot: 063533
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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