FDAMay 10, 2019device
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....
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
What to do
FDA enforcement status: Terminated
Brands named
teleflex medicalteleflex
UPCs
1402670461115414026704611161
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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