Changer, Tube, Endotracheal
Anesthesiology · 21 CFR 868.5730
Recent MDR events
39 adverse event reports on file
- CURAPLEXAug 13, 2025MalfunctionMedsource Labs Llc3003674698-2025-01032
- CURAPLEXJul 24, 2025MalfunctionMedsource Labs Llc3003674698-2025-01019
- CURAPLEXJul 18, 2025MalfunctionMedsource Labs Llc.3003674698-2025-00948
- COVIDIENMar 31, 2023MalfunctionMedtronic Inc.16655761
- PORTEX CUFF INFLATOR PRESSURE GAUGEApr 5, 2022Malfunction3012307300-2022-05828
- PORTEX ENDOTRACHEAL TUBEMar 30, 2022MalfunctionSmiths Medical International, Ltd.3012307300-2022-05561
- CURAPLEXFeb 23, 2022DeathBound Tree Medical13677981
- PORTEX CUFF PRESSURE MONITORINGJan 6, 2022Malfunction3012307300-2022-00241
- PORTEX CUFF PRESSURE MONITORINGNov 23, 2021MalfunctionSt Paul3012307300-2021-11737
- TRACHEAL TUBEOct 19, 2021Malfunction3012307300-2021-10086
Event type breakdown
Recalls
3 recall events for this product code
- Sarnova HC, LlcOpen, ClassifiedMar 19, 2024
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency.
Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
Z-1307-2024 · View FDA record ↗ - Sarnova HC, LlcOpen, ClassifiedMar 19, 2024
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency.
Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
Z-1308-2024 · View FDA record ↗ - Teleflex MedicalTerminatedNov 2, 2006
Sheridan T.T.X. Tracheal Tube Exchanger, Large Size for tracheal tube sizes 7.5 mm - 10.0 mm; a Rx, sterile, single use tracheal tube exchanger; Hudson Respirat
Biological indicator failed. Investigation eliminated all equipment and product related factors.
Z-0129-2007 · View FDA record ↗
Registered firms
2 firms currently registered for this product code
510(k) clearances
1 clearances for this product code
PMA approvals
1 premarket approvals for this product code