Tube, Bronchial (w/wo Connector)
Anesthesiology · 21 CFR 868.5720
Recent MDR events
2,475 adverse event reports on file
- SHILEYJul 31, 2026MalfunctionMallinckrodt Medical8020889-2026-00226
- SHILEYJul 31, 2026MalfunctionMallinckrodt Medical8020889-2026-00228
- SHILEYJul 30, 2026MalfunctionMallinckrodt Medical8020889-2026-00223
- SHILEYJul 28, 2026MalfunctionMallinckrodt Medical8020889-2026-00221
- RUSCH BRONCHOPART DOUBLE LUMEN RIGHTJul 28, 2026MalfunctionTeleflex Medical8040412-2026-00128
- RUSCH BRONCHOPART DOUBLE LUMEN RIGHTJul 28, 2026MalfunctionTeleflex Medical8040412-2026-00116
- SHILEYJul 17, 2026MalfunctionMallinckrodt Medical8020889-2026-00216
- RUSCH BRONCHOPART DOUBLE LUMEN RIGHTJul 13, 2026MalfunctionTeleflex Medical8040412-2026-00110
- RUSCH BRONCHOPART DOUBLE LUMEN RIGHTJul 13, 2026MalfunctionTeleflex Medical8040412-2026-00109
- RUSCH BRONCHOPART DOUBLE LUMEN LEFTJul 13, 2026MalfunctionTeleflex Medical8040412-2026-00108
Event type breakdown
Recalls
11 recall events for this product code
- Teleflex, Inc.TerminatedAug 18, 2015
Bronchial Double Lumen Tube Set (Left), Sterile
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Z-2407-2015 · View FDA record ↗ - Teleflex, Inc.TerminatedAug 18, 2015
Bronchial Double Lumen Tube Set (Right), Sterile
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Z-2408-2015 · View FDA record ↗ - Teleflex, Inc.TerminatedAug 18, 2015
Bronchial One Lumen Tube - Left
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Z-2409-2015 · View FDA record ↗ - Teleflex, Inc.TerminatedAug 18, 2015
Bronchial One Lumen Tube - Right
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Z-2410-2015 · View FDA record ↗ - Teleflex, Inc.TerminatedAug 18, 2015
Carlens Bronchial Double Lumen Tube Set (Left) Sterile
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Z-2411-2015 · View FDA record ↗ - Teleflex, Inc.TerminatedAug 18, 2015
Tracheopart Set (Left), Sterile
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Z-2412-2015 · View FDA record ↗ - Teleflex, Inc.TerminatedAug 18, 2015
Tracheopart Set (Right), Sterile
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Z-2413-2015 · View FDA record ↗ - Teleflex, Inc.TerminatedAug 18, 2015
White Bronchial Double Lumen Tube Set (Right) Sterile
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Z-2414-2015 · View FDA record ↗ - Teleflex, Inc.TerminatedAug 18, 2015
Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Z-2415-2015 · View FDA record ↗ - Teleflex MedicalTerminatedMar 19, 2014
Rusch Brochopart and Rusch Brochopart White
The product may fail to achieve seal of right lung due to the cuff inflating to one side
Z-1231-2014 · View FDA record ↗
Registered firms
12 firms currently registered for this product code
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Teleflex Medical De Tecate, S. De R.l De C.v.
TECATE Baja California, MX
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Medtronic B.v. (eoc)
HEERLEN Limburg, NL
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Cook Incorporated
Bloomington, IN, US
Covidien
Lafayette, CO, US
Teleflex Medical Llc
Morrisville, NC, US
Rhenus Se & Co. Kg
Holzwickede North Rhine-Westphalia, DE
Mallinckrodt Medical
ATHLONE Westmeath, IE
Burak Global Ic Ve Dis Tic Ltd Sti
Kocasinan Kayseri, TR
510(k) clearances
6 clearances for this product code
- Rusch, Inc.Nov 27, 1995
K953963 · RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION
- Rusch Intl.Jun 8, 1995
K951091 · RUSCH ENDOBRONCHIAL TUBE SETS
- Concord/PortexAug 3, 1990
K902116 · MODIFIED ENDOBRONCHIAL TUBE
- Portex, Inc.Jan 17, 1984
K834565 · ENDOBRONCHIAL TWIN LUMEN TUBE
- SurgitekDec 27, 1983
K833297 · BRONCHOSCOPY TUBE W/ULTRA LOCUFF
- Mallinckrodt Critical CareAug 4, 1977
K771219 · BRONCHO-CATH