Recall record at a glance
| Official record | Z-1912-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Teleflex Medical |
| Report date | Jul 24, 2019 |
| Recall initiation date | May 10, 2019 |
| Quantity | 20 units |
| Location | Morrisville, NC, United States |
Official product description
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.
Why the product was recalled
Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
Distribution information
US Nationwide Distribution in the states of AL, TX
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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