Agency classClass IIOur severity:High FDA (Devices)·Z-0055-2015·Announced 2014-10-15

Bio-Detek Recalls ZOLL Pro-padz Sterile Adult Electrodes Due to Sterility Concerns

Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because product sterility is not assured. The recall affects 41 single units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a risk-of-harm product (sterility not assured) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, part number 8900-4055-40. The recall is being conducted because product sterility is not assured. These disposable, single-use electrodes are intended for use in a sterile environment by trained medical professionals in connection with ZOLL Defibrillators for adult patients.

The affected product includes 41 single units from lot numbers 1614, 1914, and 2114. The products were distributed worldwide, including in the United States, Australia, Canada, Belgium, France, and Germany. The electrodes are used for defibrillation, cardioversion, external non-invasive pacing, and monitoring.

Healthcare facilities and consumers should stop using the affected electrodes and contact Bio-Detek, Inc. for further instructions or a return. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed…
Manufacturer: Bio-Detek, Inc.
Category: Medical Device — Defibrillator Electrodes
Hazard: sterility-failure
infection-risk
Affected units: 41

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lot Numbers: 1614
1914
2114

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Bio-Detek, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Bio-Detek, Inc.

See all →

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FDA (Devices) · 2019-07-10
High
Zoll Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns
FDA (Devices) · 2014-10-15
High
ZOLL Pro-padz Sterile Adult Electrodes Recalled Due to Sterility Concerns
FDA (Devices) · 2014-10-15
High
ZOLL Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns
FDA (Devices) · 2014-10-15
High
ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues
FDA (Devices) · 2014-09-24

Same hazard · sterility failure