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Recall Observatory FDA recall evidence

Device product

Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022

Z-2547-2015

August 19, 2015

Class II

Product summary

Firm
Covidien LLC
Event
Event 71963
Status
Terminated
Classification
Class II
Quantity
56,000 sets
Official record key
device-enforcement:Z-2547-2015

Official wording

Reason: 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

Code information: Lot Numbers: 516907, 519815, 519816

Distribution pattern: Nationwide Foreign: Canada Australia Denmark Germany New Zealand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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