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Terminated

Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, 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.

FDA Recall Z-0500-2013 · Posted 2012-12-10

Recall StatusTerminated
Product CodeGXY
Date Initiated2012-02-09
Date Terminated2013-01-03
Product Quantity3290

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.

Firm 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.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution including CA, IL, MA, MN, and SD.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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