Bio-Detek recalls ZOLL Pro-padz Liquid Gel Radiolucent devices with part numbers 8900-2105-01 and 8900-2106-01 due to potential incorrect electrode assembly, which may prevent defibrillation or pacing therapy.
Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
Bio-Detek is recalling ZOLL Pro-padz Liquid Gel Radiolucent devices that may have incorrect electrode assembly, preventing proper defibrillation or pacing therapy. This could lead to life-threatening situations if the device fails during an emergency.
Incorrect electrode assembly in some units can prevent the device from delivering necessary defibrillation or pacing therapy. This means the device might fail during an emergency, potentially causing serious harm or death.
Medical professionals using these devices for defibrillation or pacing therapy are most at risk. Patients relying on the device for critical care may also be affected.
Check for part numbers 8900-2105-01 (12/case) or 8900-2106-01 (single) on the device. The recall includes lots 1719, 1719A, and 1819.
Look for part numbers 8900-2105-01 (12/case) or 8900-2106-01 (single) on the device.
Contact Bio-Detek directly for further instructions on how to address the issue.
Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
Part numbers 8900-2105-01 (12/case) and 8900-2106-01 (single).
Check for part numbers 8900-2105-01 (12/case) or 8900-2106-01 (single) on the device. The recall includes lots 1719, 1719A, and 1819.
We’ve drafted a message you can send Bio-Detek to request your refund or repair — edit it as you like.
Subject: Recall Z-1945-2019 — Bio-Detek Bio-Detek Hello, I own a Bio-Detek that is covered by recall Z-1945-2019 from Bio-Detek. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
