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Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
FDA product code CBI · Class 2 · Anesthesiology
285
Registered devices
1,573
Adverse events
10
Recalls
34
510(k) clearances
Devices with this code
HUDSON RCI — TELEFLEX INCORPORATEDANKOR endobronchial tube — INSUNG MEDICAL Co., Ltd..Endobronchial Tube — Well Lead Medical Co.,LtdVivaSight AS Pack Set include — E.T. VIEW LTDNA — Henan Tuoren Medical Device Co.,Ltd.HUDSON RCI — TELEFLEX INCORPORATEDInsighters — Shenzhen Insighters Medical Technology Co., Ltd.NA — Henan Tuoren Medical Device Co.,Ltd.Endobronchial Tube — Well Lead Medical Co.,LtdRUSCH — TELEFLEX INCORPORATEDInsighters — Shenzhen Insighters Medical Technology Co., Ltd.SHERIDAN — TELEFLEX INCORPORATEDSILBRONCHO (LEFT LUNG) — FUJI SYSTEMS CORPORATIONParker — SALTER LABSUNIVENT TUBE (TCB TYPE) — FUJI SYSTEMS CORPORATIONForsure — FORSURE MEDICAL PRODUCTS LLCVivaSight DL AS Set Includes — E.T. VIEW LTDNA — Henan Tuoren Medical Device Co.,Ltd.Parker Flex-Tip — SALTER LABSHuman-broncho endobronchial tube — INSUNG MEDICAL Co., Ltd..RUSCH — TELEFLEX INCORPORATEDVivaSight-EB — E.T. VIEW LTDANKOR endobronchial tube — INSUNG MEDICAL Co., Ltd..SHERIDAN — TELEFLEX INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-16 | Ambu Inc. | Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of compli |
| 2022-06-03 | Ambu Inc. | Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secu |
| 2019-10-30 | Teleflex Medical | The tracheal and brochial swivel connectors are incorrectly labeled. |
| 2016-12-16 | Parker Medical | The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function a |
| 2015-06-01 | Teleflex Medical | The double swivel connector may crack or separate on the endobronchial tube. |
| 2015-06-01 | Teleflex Medical | The double swivel connector may crack or separate on the endobronchial tube. |
| 2015-06-01 | Teleflex Medical | The double swivel connector may crack or separate on the endobronchial tube. |
| 2015-06-01 | Teleflex Medical | The double swivel connector may crack or separate on the endobronchial tube. |
| 2005-02-23 | Teleflex Medical | The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and |
| 2005-02-23 | Teleflex Medical | The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and |
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