# FDA recall Z-2055-2019

> **InfuTronix LLC** · Class II · device recall initiated 2019-05-28.

## Product

Nimbus Administration Set, REF HS-004, UDI # 00817170020031    Product Usage:  Administer fluids/medication from a container to a patient through a needle or a catheter.

## Reason for recall

Potential for tube leakage

## Distribution

US distribution in the state of MA

## Key facts

- **Recall number:** Z-2055-2019
- **Recalling firm:** InfuTronix LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-28
- **Report date:** 2019-07-31
- **Termination date:** 2020-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Natick, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2055-2019

## Citation

> AI Analytics. FDA recall Z-2055-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2055-2019. Source: US FDA. Licensed CC0.

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