# FDA recall Z-1912-2019

> **Teleflex Medical** · Class I · device recall initiated 2019-05-10.

## Product

Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column:   a) REF 870-07KIT   b) REF 870-09KIT    Product Usage:  The Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to an infant/neonate patient. These gases may be delivered by nasal prongs using the CareFusion Infant Flow system and the single limb circuit, or through bypassing upper airways, for example through the use of an endotracheal tube with the dual limb configuration.

## Reason for recall

Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.

## Distribution

US Nationwide Distribution in the states of AL, TX

## Key facts

- **Recall number:** Z-1912-2019
- **Recalling firm:** Teleflex Medical
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-10
- **Report date:** 2019-07-24
- **Termination date:** 2024-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1912-2019

## Citation

> AI Analytics. FDA recall Z-1912-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1912-2019. Source: US FDA. Licensed CC0.

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