CLASS II Device recall · Reported 15 Oct 2014 · FDA Enforcement Report
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single recalled
Bio-Detek is recalling ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single, distributed nationwide in the US. The recall was initiated on 16 Sep 2014 and the FDA has classified it as Class II.
Check your package
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-0053-2015
- FDA event ID
- 69409
- Recalling firm
- Bio-Detek, Pawtucket, RI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Sep 2014
- FDA classified
- 8 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Pacemakers & Defibrillators
Timeline
| 16 Sep 2014 | Recall initiated by company | |
| 8 Oct 2014 | Classified by FDA | +22 days |
| 15 Oct 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
Product sterility 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 Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
Questions about this recall
Is ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single recalled?
Yes. Bio-Detek recalled ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single on 16 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-0053-2015.
Why was it recalled?
Product sterility is not assured
Which lots are affected?
Lot Numbers: 1614, 1814
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bio-Detek
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers recalled by Bio-Detek | Bio-Detek | Other | Nationwide |
| Device | CLASS II | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) recalled | Bio-Detek | Sterility | Nationwide |
| Device | CLASS II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes recalled | Bio-Detek | Sterility | Nationwide |
| Device | CLASS II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes recalled | Bio-Detek | Sterility | Nationwide |
| Device | CLASS II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) recalled | Bio-Detek | Sterility | Nationwide |
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