Bio-Detek, Inc. recalls ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
- Recall date
- May 28, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1945-2019
- FDA classification
- Class II
- Brand / firm
- Bio-Detek, Inc.
- Sold / distributed
- 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.
Why it was recalled
Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
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