Food, drugs, devices › Bio-Detek, Inc.
Device recall: ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are use
FDA enforcement event 69409 is a device recall by Bio-Detek, Inc. of Pawtucket, RI, initiated 16 Sep 2014 and classified Class II, with 4 product records.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 3 May 2016. Initiation: voluntary: firm initiated. Bio-Detek, Inc. has 4 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bio-Detek, Inc., Pawtucket, RI.
Reason for recall
"Product sterility is not assured"
Distribution
"Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0052-2015 | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 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… | 237 cases (6/case) | Class II | Terminated | 15 Oct 2014 |
| Z-0053-2015 | 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,… | 18 singles | Class II | Terminated | 15 Oct 2014 |
| Z-0054-2015 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 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/… | 193 cases (6/case) | Class II | Terminated | 15 Oct 2014 |
| Z-0055-2015 | 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 through Gamma Radiation to a SAL of 10-6 per… | 41 singles | Class II | Terminated | 15 Oct 2014 |
Context
Other enforcement events for Bio-Detek, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 May 2019 | ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) | Device | Class II | 1 |
| 26 Aug 2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection | Device | Class II | 3 |
| 12 Mar 2013 | Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15 | Device | Class II | 1 |
All 4 events for Bio-Detek, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Product sterility is not assured"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 May 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.