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U.S. Department of Health and Human Services

Class 2 Device Recall Prostate Biopsy Needle

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  Class 2 Device Recall Prostate Biopsy Needle see related information
Date Initiated by Firm January 19, 2007
Date Posted March 29, 2007
Recall Status1 Terminated 3 on May 11, 2007
Recall Number Z-0673-2007
Recall Event ID 37600
510(K)Number K982401  
Product Classification Biopsy Needle - Product Code KNW
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.
Code Information Lot: 063533
Recalling Firm/
Manufacturer		 Remington Medical Inc.
6830 Meadowridge Ct.
Alpharetta GA 30005
For Additional Information Contact Don Rosvild
770-888-8520
Manufacturer Reason
for Recall		 Pouches were not sealed prior to sterilization.
FDA Determined
Cause 2		 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.
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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