Z-0673-2007

Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized...

Name: Z-0673-2007 Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized...
Creator: Remington Medical Inc.
Published: 2007-01-19
License: https://open.fda.gov/license/

Remington Medical / initiated 2007-01-19 / Terminated / root cause: packaging

FDA source

Remington Medical Inc. began a recall of Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005 on 2007-01-19. The reason FDA records is "Pouches were not sealed prior to sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0673-2007
Status: Terminated
Initiated: 2007-01-19
Posted: 2007-03-29
Terminated: 2007-05-11
Recalling firm: Remington Medical
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.
Product code: KNW Instrument, Biopsy
Reason for recall: Pouches were not sealed prior to sterilization.
Root cause tag: packaging
FDA 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 in commerce: 192 units
Distribution: Nationwide.
Product codes and lots: Lot: 063533

Product code KNW

K982401Class IIProstate Biopsy NeedleRemington Medical, Inc. / cleared 1998-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)