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U.S. Department of Health and Human Services

Class 2 Device Recall Empi STIMC RE Self Adhesive electrodes

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  Class 2 Device Recall Empi STIMC RE Self Adhesive electrodes see related information
Date Initiated by Firm February 09, 2012
Date Posted December 10, 2012
Recall Status1 Terminated 3 on January 03, 2013
Recall Number Z-0501-2013
Recall Event ID 61209
510(K)Number K902195  
Product Classification Electrode, cutaneous - Product Code GXY
Product Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand
A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Code Information Lots 200300 and 201203
Recalling Firm/
Manufacturer		 Covidien LLC dba Uni-Patch
1313 Grant Blvd W
Wabasha MN 55981-1058
For Additional Information Contact Customer Service
651-565-5728
Manufacturer Reason
for Recall		 Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.
FDA Determined
Cause 2		 Employee error
Action Covidien sent An Urgent Product Recall letter, dated February 9, 2012, to all affected consignees. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the affected product if found. The letter asked customers to fill in teh quantity remaining in their inventory and fax it to 651-565-5888. A Covidien Customer Service rep would contact the consignee for returning product. Consignees were also requested to notify their customers of the recall. For questions regarding this recall call 508-261-8532.
Quantity in Commerce 28,138 pouches
Distribution Nationwide Distribution including CA, IL, MA, MN, and SD.
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 = GXY and Original Applicant = EMPI
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