Recall Z-2545-2015 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Covidien LLC
MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
| Date | Sep 2, 2015 (initiated Aug 19, 2015) |
| Status | Terminated |
| Reason | Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns |
| Root cause | Process control |
| Action | Medtonic/Covidien issued recall letter on August 19, 2015. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 2 Ludlow Park Drive, Chicopee, MA 01022, Attention: Field Action Returns. Contact your Medtronic representative or Customer Service at (800)-882-5878. |
| Quantity | 7660 sets |
| Distribution | Nationwide Foreign: Canada Australia Denmark Germany New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012218 | LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES The Ludlow Company LP, Oct 12, 2001 |