CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report

MediTrace Cadence Adult Zoll recalled by Covidien

Covidien is recalling MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile, distributed nationwide in the US. The recall was initiated on 19 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 516313X, 519124X, 513426X

Quantity recalled114,000 sets

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2546-2015
FDA event ID: 71963
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Terminated
Recall initiated: 19 Aug 2015
FDA classified: 2 Sep 2015
Reported: 9 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Aug 2015	Recall initiated by company
2 Sep 2015	Classified by FDA	+14 days
9 Sep 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC

Where it was distributed

Nationwide Foreign: Canada Australia Denmark Germany New Zealand

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Numbers: 516313X, 519124X, 513426X

Where was it sold?

Nationwide Foreign: Canada Australia Denmark Germany New Zealand

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 71963

Reported	Class	Recall	Company	Reason	Where
9 Sep 2015	CLASS II	Physio-Control QuikCombo Pacing/Defibrillation/ECG recalled by Covidien	Covidien	Other	Nationwide
9 Sep 2015	CLASS II	MediTrace Cadence Adult Multi-Function Defibrillation Electrodes recalled	Covidien	Other	Nationwide

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