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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