Drug recall
Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a)…
FDA recall event 82994 · Class I · Teleflex Medical
Key facts
| Event ID | 82994 |
|---|---|
| Recall numbers | Z-1912-2019 |
| Recalling firm | Teleflex Medical |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit. |
| Initiation date | May 10, 2019 |
| Report date | Jul 24, 2019 |
| Termination date | Apr 22, 2024 |
| City | Morrisville |
| State | NC |
| Country | United States |
| FEI number | 3005747797 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: