Reported Jul 10, 2019 · Terminated

ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)

Bio-Detek, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bio-Detek, Inc. · 525 Narragansett Park Dr · Pawtucket, RI · 02861-4323

Is this the product you have?

  • ZOLL Pro-padz Liquid Gel Radiolucent
  • Part numbers8900-2105-01 (12/case) and 8900-2106-01 (single)
Lot codes and dates
    • Lots 1719
    • 1719A
    • and 1819
Amount recalled
1789

Where it was sold

Why it was recalled

Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 1, 2020 · Data as of Sep 19, 4:52 PM UTC

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