PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 9, 2015 Initiated: August 19, 2015 #Z-2547-2015

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Covidien LLC
Units Affected
56,000 sets
Distribution
Nationwide Foreign: Canada Australia Denmark Germany New Zealand
Location
North Haven, CT

Frequently Asked Questions

What product was recalled?
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022. Recalled by Covidien LLC. Units affected: 56,000 sets.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Devices on September 9, 2015. Severity: Moderate. Recall number: Z-2547-2015.