Reported Jul 24, 2019 · Terminated
Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF…
Teleflex Medical
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teleflex Medical · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with
- Dual Heated Limb and ConchaSmart Columna) REF 870-07KIT
- b) REF 870-09KIT Product UsageThe 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
- Lot codes and dates
- Lot/ Batch Number GTIN a) 74L1802045 14026704611154 b) 74L1802044 14026704611161
- Amount recalled
- 20 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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