Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual… — Class I medical device recall Z-1912-2019
Terminated recall by Teleflex Medical, reported 2019-07-24, distributed nationwide. Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart
| Recall number | Z-1912-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Morrisville, NC, United States |
| Recall initiated | 2019-05-10 |
| Classified | 2019-07-15 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2024-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 20 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 14026704611154, 14026704611161 |
| Model numbers | 870-07KIT, 870-09KIT |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1912-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.