Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion
FDA device recall Z-1184-2013 · posted 2013-04-29 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DRO
- Quantity affected
- 133470 (sets of 2)
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
- Date initiated
- 2013-04-08
- Date posted
- 2013-04-29
- Date terminated
- 2015-11-19
- Location
- Mansfield, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (K012218) | The Ludlow Company LP | 2001-10-12 |