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.
Recall
- Recall Number
- Z-0499-2013
- Event Number
- 61209
- Firm
- Covidien LLC dba Uni-Patch
- FEI Number
- 1000116809
- Product Code
- GXY
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- February 9, 2012
- Posted
- December 10, 2012
- Terminated
- January 3, 2013
- Address
- 1313 Grant Blvd W, Wabasha, MN, 55981-1058
Description
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.
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.
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.
Nationwide Distribution including CA, IL, MA, MN, and SD.
3594 pouches