Medical device recalls Moderate risk

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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