FDAClass IISeptember 9, 2015

Physio-Control QuikCombo Pacing/Defibrillation/ECG recall

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

Why was Physio-Control QuikCombo Pacing/Defibrillation/ECG 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 516907, 519815, 519816

Product
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022
Recalling firm
Covidien LLC
Quantity
56,000 sets
Distribution
Nationwide Foreign: Canada Australia Denmark Germany New Zealand
Recall date
September 9, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls