FDA-Device2015-09-09Class II

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

Covidien LLC
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

Sold states
Nationwide Foreign: Canada Australia Denmark Germany New Zealand
Affected count
56,000 sets
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2547-2015

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