Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is
FDA device recall Z-0500-2013 · 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
- 3290
- 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
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELECTRODE USING PROMEON RG-60 SERIES GEL (K915333) | Labeltape Meditect, Inc. | 1992-01-14 |