# FDA recall Z-2108-2021

> **Mindray DS USA, Inc. dba Mindray North America** · Class III · device recall initiated 2021-05-27.

## Product

3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00).  Used with physiological data monitor.

## Reason for recall

Telepack may not power on when using the 3AA battery cradle.

## Distribution

Distributed US nationwide and Canada.

## Key facts

- **Recall number:** Z-2108-2021
- **Recalling firm:** Mindray DS USA, Inc. dba Mindray North America
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-27
- **Report date:** 2021-07-28
- **Termination date:** 2022-08-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2108-2021

## Citation

> AI Analytics. FDA recall Z-2108-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2108-2021. Source: US FDA. Licensed CC0.

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