Device 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.
Z-1912-2019
Product summary
- Firm
- Teleflex Medical
- Event
- Event 82994
- Status
- Terminated
- Classification
- Class I
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1912-2019
Official wording
Reason: Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
Code information: Lot/ Batch Number GTIN a) 74L1802045 14026704611154 b) 74L1802044 14026704611161
Distribution pattern: US Nationwide Distribution in the states of AL, TX
Derived failure modes
-
Unknown
Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.