FDA Medical Device Recalls (openFDA)
Remington Medical Inc.: Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.
- Recall number
- Z-0673-2007
- Recalling firm
- Remington Medical Inc.
- Product
- Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.
- Status
- Terminated
- Initiated
- 2007-01-19
- Posted
- 2007-03-29
- Terminated
- 2007-05-11
- Reason
- Pouches were not sealed prior to sterilization.
- Root cause
- Other
- Action
- 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.
- Quantity
- 192 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot: 063533
- 510(k) numbers
- ["K982401"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 1000132370
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28