# FDA recall Z-1945-2019

> **Bio-Detek, Inc.** · Class II · device recall initiated 2019-05-28.

## Product

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

## 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.

## Key facts

- **Recall number:** Z-1945-2019
- **Recalling firm:** Bio-Detek, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-28
- **Report date:** 2019-07-10
- **Termination date:** 2020-06-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pawtucket, RI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1945-2019

## Citation

> AI Analytics. FDA recall Z-1945-2019. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1945-2019. Source: US FDA. Licensed CC0.

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