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U.S. Department of Health and Human Services

Class 2 Device Recall MIDAS TOUCH NEEDLE ELECTRODE

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  Class 2 Device Recall MIDAS TOUCH NEEDLE ELECTRODE see related information
Date Initiated by Firm September 24, 2009
Date Posted November 10, 2009
Recall Status1 Terminated 3 on October 05, 2010
Recall Number Z-0140-2010
Recall Event ID 53482
510(K)Number K973234  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Olsen Medical, MIDAS TOUCH ¿ NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013, 30-1014 and 30-6011.
Code Information Model Number: 30-1011, Lot Numbers: 011898, 012733, 012988 and 013373; Model Number: 30-1012, Lot Number: 012244; Model Number: 30-1013, all lots; Model Number: 30-1014, Lot Numbers: 011668, 011970 and 012997; and Model Number: 30-6011, Lot Numbers: 012565, 012800 and 012983.
Recalling Firm/
Manufacturer		 Kentucky Packaging Service LP
3001 W Kentucky St
Louisville KY 40211-1505
For Additional Information Contact John P. Waters
502-772-4272 Ext. 5030
Manufacturer Reason
for Recall		 THERE WERE INCONSISTENCIES NOTICED ON THE INSULATION OVERLAP. THE ELECTRODE HAS A LARGE DIAMETER SHAFT THAT TRANSITIONS TO A SMALLER DIAMETER SHAFT. THE 1ST LAYER OF INSULATION WHICH COVERS THE SMALL DIAMETER SHAFT OVERLAPS WITH THE 2ND LAYER OF INSULATION THAT COVERS THE LARGER DIAMETER SHAFT. ON SOME ELECTRODES IT APPEARS THAT THE OVERLAP IS TOO SHORT TO COVER THE TRANSITION WHICH MAKES THIS
FDA Determined
Cause 2		 Process control
Action Olsen Medical issued an "Urgent: Device Recall" letter to Consignees beginning September 24, 2009 . Customers were instructed to inventory their stock and for all remaining product immediately discontinue use and return. Consignees were also instructed to contact their customers and notify them of the recall. For further information, contact Olsen Medical at 1-502-772-4272.
Quantity in Commerce 3,617 pieces
Distribution Nationwide Distribution -- AZ, FL, IA, MD, MO, NM, OR, NV, TN, TX and VA.
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 = GEI and Original Applicant = ITI MEDICAL TECHNOLOGIES, INC.
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