CLASS I Device recall · Reported 24 Jul 2019 · FDA Enforcement Report

Teleflex Hudson Rdi Neonatal ConchaSmart Breathing Circuit recalled

Teleflex Medical is recalling Teleflex Hudson Rdi Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and, distributed nationwide in the US. The recall was initiated on 10 May 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot/ Batch Number GTIN a) 74L1802045 14026704611154 b) 74L1802044 14026704611161

Quantity recalled20 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1912-2019
FDA event ID: 82994
Recalling firm: Teleflex Medical, Morrisville, NC
Classification: Class I
Status: Terminated
Recall initiated: 10 May 2019
FDA classified: 15 Jul 2019
Reported: 24 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Masks, Gloves & PPE

Timeline

10 May 2019	Recall initiated by company
15 Jul 2019	Classified by FDA	+66 days
24 Jul 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide Distribution in the states of AL, TX

Nationwide Alabama Texas

Questions about this recall

Is Teleflex Hudson Rdi Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and recalled?

Yes. Teleflex Medical recalled Teleflex Hudson Rdi Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and on 10 May 2019. The recall is Class I and its status is Terminated. Recall number Z-1912-2019.

Why was it recalled?

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

Which lots are affected?

Lot/ Batch Number GTIN a) 74L1802045 14026704611154 b) 74L1802044 14026704611161

Where was it sold?

US Nationwide Distribution in the states of AL, TX

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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