Z-0028-2013Class II

Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830...

Name: Z-0028-2013 Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830...
Creator: Remington Medical Inc.
Published: 2012-08-29
License: https://open.fda.gov/license/

Remington Medical / initiated 2012-08-29 / Terminated / root cause: manufacturing process

FDA source

Remington Medical Inc. began a recall of Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate... on 2012-08-29. FDA classified it as Class II and gives the reason as "Sterility of the product may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0028-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-29
Posted: 2012-10-09
Terminated: 2013-01-15
Recalling firm: Remington Medical
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.
Product code: KNW Instrument, Biopsy
Reason for recall: Sterility of the product may be compromised.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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.
Quantity in commerce: 800 needles
Distribution: Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.
Product codes and lots: NAC-1820M, Lot number: 121003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0028-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0028-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09

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)