FDAClass IIDecember 19, 2012

Empi STIMC RE Self Adhesive electrodes. For use on TENS recall

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…

Why was Empi STIMC RE Self Adhesive electrodes. For use on TENS recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots 200300 and 201203

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…
Recalling firm
Covidien LLC dba Uni-Patch
Quantity
28,138 pouches
Distribution
Nationwide Distribution including CA, IL, MA, MN, and SD.
Recall date
December 19, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls