Recalls / —
—#139462
Product
MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
- FDA product code
- DRO — Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K012218
- Affected lot / code info
- Lot Numbers: 516313X, 519124X, 513426X
Why it was recalled
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 (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Covidien LLC
- Address
- 60 Middletown Ave, North Haven, Connecticut 06473-3908
Distribution
- Distribution pattern
- Nationwide Foreign: Canada Australia Denmark Germany New Zealand
Timeline
- Recall initiated
- 2015-08-19
- Posted by FDA
- 2015-09-02
- Terminated
- 2017-05-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #139462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.