The Recall Desk

FDA (Devices) recall action 64868

Covidien LLC recalled 2 products on 2013-05-08

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-05-08
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • SevereFDA (Devices)··2013-05-08

    Medi-Trace Pediatric Defibrillation Electrodes Recalled for Arcing Risk

    FDA is recalling Medi-Trace Cadence Pediatric Defibrillation Electrodes because arcing or sparking may damage the leadwire, preventing the device from delivering appropriate energy to patients.

    Product
    Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-05-08

    Medi-Trace Cadence Adult Defibrillation Electrodes Recalled for Thermal Damage Risk

    FDA is recalling Medi-Trace Cadence Adult Defibrillation Electrodes because arcing or sparking may cause thermal damage to the leadwire, potentially preventing the device from delivering appropriate energy to patients.

    Product
    Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
    Category
    Distribution
    0 states