FDAFDA · Food and drugs·Recall number Z-2547-2015
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022
Published September 9, 2015 · Recall initiated: August 19, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LLC
- Distributor
- Nationwide Foreign: Canada Australia Denmark Germany New Zealand
- Lot
- Lot Numbers: 516907, 519815, 519816
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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