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U.S. Department of Health and Human Services

Class 2 Device Recall Reusable, SelfAdhering TENS/NMES/FES electrodes

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 Class 2 Recall
Reusable, SelfAdhering TENS/NMES/FES electrodes
see related information
Date Posted December 10, 2012
Recall Status1 Terminated on January 03, 2013
Recall Number Z-0499-2013
Recall Event ID 61209
Premarket Notification
510(K) Number
K900519 
Product Classification Electrode, Cutaneous - Product Code GXY
Product Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
Code Information Lots 202404, 202506, 203431,
Recalling Firm/
Manufacturer
Covidien LLC dba Uni-Patch
1313 Grant Blvd W
Wabasha, Minnesota 55981-1058
Consumer Instructions Contact the recalling firm for information
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
TRAINING: 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 3594 pouches
Distribution Nationwide Distribution including CA, IL, MA, MN, and SD.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GXY and Original Applicant = CLASSIC MEDICAL PRODUCTS, INC.
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