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U.S. Department of Health and Human Services

Class 2 Device Recall Vector Selector Cable Switch

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  Class 2 Device Recall Vector Selector Cable Switch see related information
Date Initiated by Firm August 31, 2005
Date Posted November 03, 2005
Recall Status1 Terminated 3 on May 09, 2007
Recall Number Z-0124-06
Recall Event ID 33490
510(K)Number K050884  
Product Classification Tester, Pacemaker Electrode Function - Product Code DTA
Product Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical Incorporated, 6830 Meadowridge Court, Alpharetta, GA 30005, (770) 888-8520 or (800) 999-0057 * Distributed By: Guidant Corporation, 4100 Hamine Avenue North, St. Paul, MN 55112-5798 USA.
Code Information Lot number: 051781, 051782, 051783, 051788, 0517939.
Recalling Firm/
Manufacturer		 Remington Medical Inc.
6830 Meadowridge Ct
Alpharetta GA 30005-2202
For Additional Information Contact Maria Granito
770-989-0057
Manufacturer Reason
for Recall		 The vector selector has an electrical design flaw which prevents RV pacing.
FDA Determined
Cause 2		 Other
Action Guidant Corporation notified Remington Medical of the problem. Remington had instructed Guidant to retrieve the product from their sales force by 09/07/2005 and return to Remington by 09/09/2005.
Quantity in Commerce 600 units
Distribution MN
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 = DTA and Original Applicant = REMINGTON MEDICAL, INC.
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