Food, drugs, devices › Bio-Detek, Inc.
Device recall: ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Bio-Detek, Inc. (Pawtucket, RI) initiated this device recall on 28 May 2019; FDA lists 1 product record under event 83040, classified Class II.
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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 1 Jun 2020. 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
"Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy."
Distribution
"Distributed to accounts in AZ, CA, CO, CT, FL, LA, MN, NV, OH, PA, TN, UT, and WY. International distribution to Canada, Germany, France, and Italy."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1945-2019 | ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) | 1789 | Class II | Terminated | 10 Jul 2019 |
Context
Other enforcement events for Bio-Detek, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Sep 2014 | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are use | Device | Class II | 4 |
| 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: "Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy."
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: "Distributed to accounts in AZ, CA, CO, CT, FL, LA, MN, NV, OH, PA, TN, UT, and WY. International distribution to Canada, Germany, France, and Italy."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Jun 2020. "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.