Class I — Teleflex Medical
| Recalling firm | Teleflex |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit. |
| 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. |
| Quantity | 20 units |
| Distribution | US Nationwide Distribution in the states of AL, TX |
| Initiated | 2019-05-10 |
| Classified | 2019-07-15 |
| Terminated | 2024-04-22 |
| Recall number | Z-1912-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Teleflex Medical (Z-1912-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82994/
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