# FDA recall Z-0200-2025

> **Smiths Medical ASD, Inc.** · Class II · device recall initiated 2024-09-24.

## Product

medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547

## Reason for recall

Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0200-2025
- **Recalling firm:** Smiths Medical ASD, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-24
- **Report date:** 2024-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0200-2025

## Citation

> AI Analytics. FDA recall Z-0200-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0200-2025. Source: US FDA. Licensed CC0.

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