# FDA recall Z-1776-2018

> **Transonic Systems Inc** · Class II · device recall initiated 2018-02-15.

## Product

Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40    The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.

## Reason for recall

The sterility of the device cannot be assured. There is a potential for an increased risk of infection.

## Distribution

Worldwide Distribution - USA (nationwide) Distribution and to the states of :  NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan.

## Key facts

- **Recall number:** Z-1776-2018
- **Recalling firm:** Transonic Systems Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-15
- **Report date:** 2018-05-16
- **Termination date:** 2019-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ithaca, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1776-2018

## Citation

> AI Analytics. FDA recall Z-1776-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1776-2018. Source: US FDA. Licensed CC0.

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