Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an e

FDA device recall Z-0498-2013 · posted 2012-12-10 · Terminated

Recall details

Recalling firm

Covidien LLC dba Uni-Patch

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.

Action taken

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

Status

Terminated

Product code

GXY

Quantity affected

2,014 pouches

Distribution

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

Date initiated

2012-02-09

Date posted

2012-12-10

Date terminated

2013-01-03

Location

Wabasha, MN

Related 510(k) clearances