Recall Z-1185-2013 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Covidien LLC
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
| Date | Apr 29, 2013 (initiated Apr 8, 2013) |
| Status | Terminated |
| Reason | Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient |
| Root cause | Process control |
| Action | Covidien sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 8, 2013 to all affected customers. The letter identifies the product, problem and requests that customers immediately stop using and segregate any affected product from inventory. Questions:Call 1-800-962-9888 option 8, then extension 2500. |
| Quantity | 7485 (sets of 2) |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa. |
| 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 |