CLASS II Device recall · Reported 24 Sep 2014 · FDA Enforcement Report

ZOLL Pro-padz Sterile Adult Multi-Function Electrodes recalled

Bio-Detek is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, distributed nationwide in the US. The recall was initiated on 26 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 2314

Quantity recalled100 cases =600 units

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-2660-2014
FDA event ID: 69145
Recalling firm: Bio-Detek, Pawtucket, RI
Classification: Class II
Status: Terminated
Recall initiated: 26 Aug 2014
FDA classified: 17 Sep 2014
Reported: 24 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Pacemakers & Defibrillators

Timeline

26 Aug 2014	Recall initiated by company
17 Sep 2014	Classified by FDA	+22 days
24 Sep 2014	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

Sterility of device is not assured

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.

Nationwide

Questions about this recall

Why was it recalled?

Sterility of device is not assured

Which lots are affected?

Lot Number: 2314

Where was it sold?

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.

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 69145

Reported	Class	Recall	Company	Reason	Where
24 Sep 2014	CLASS II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes recalled	Bio-Detek	Sterility	Nationwide
24 Sep 2014	CLASS II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) recalled	Bio-Detek	Sterility	Nationwide

More recalls from Bio-Detek

All 9

Reported	Class	Recall	Company	Reason	Where
10 Jul 2019Device	CLASS II	ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers recalled by Bio-Detek	Bio-Detek	Other	13 states
15 Oct 2014Device	CLASS II	ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single recalled	Bio-Detek	Sterility	Nationwide
15 Oct 2014Device	CLASS II	ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) recalled	Bio-Detek	Sterility	Nationwide
15 Oct 2014Device	CLASS II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes recalled	Bio-Detek	Sterility	Nationwide
15 Oct 2014Device	CLASS II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes recalled	Bio-Detek	Sterility	Nationwide

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