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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 15, 2005
Date Posted April 08, 2005
Recall Status1 Terminated 3 on May 17, 2005
Recall Number Z-0697-05
Recall Event ID 31527
510(K)Number K982401  
Product Classification Instrument, Biopsy - Product Code KNW
Product Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005.
Code Information Lot number 043351 & 043272
Recalling Firm/
Manufacturer		 Remington Medical Inc.
6830 Meadowridge Ct
Alpharetta GA 30005-2202
For Additional Information Contact Maria Granito
800-989-0057
Manufacturer Reason
for Recall		 The stylet hub detaches from the stylet needle.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 02/15/2005.
Quantity in Commerce 1737 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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