MediTrace Cadence Adult Zoll recalled over sterility concerns

Recall date

August 19, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Covidien LLC recalls MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC

Recall number

Z-2546-2015

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Nationwide Foreign: Canada Australia Denmark Germany New Zealand

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC