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U.S. Department of Health and Human Services

Class 2 Device Recall Automatic Cutting Needles

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  Class 2 Device Recall Automatic Cutting Needles see related information
Date Initiated by Firm August 29, 2012
Date Posted October 09, 2012
Recall Status1 Terminated 3 on January 15, 2013
Recall Number Z-0028-2013
Recall Event ID 63070
510(K)Number K982401  
Product Classification Instrument, biopsy - Product Code KNW
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.
Code Information NAC-1820M, Lot number: 121003
Recalling Firm/
Manufacturer		 Remington Medical Inc.
6830 Meadowridge Ct.
Alpharetta GA 30005
For Additional Information Contact Christopher M. Brown
770-888-8520 Ext. 218
Manufacturer Reason
for Recall		 Sterility of the product may be compromised.
FDA Determined
Cause 2		 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: tracyw@remmed.com; 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNW and Original Applicant = REMINGTON MEDICAL, INC.
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