NA
Henan Tuoren Medical Device Co.,Ltd. · Model Right:Fr35 · UDI-DI 06938119326596
CBI
Prescription
1
510(k) clearances
1,573
Adverse events (12 deaths)
10
Recalls
36
Facilities
Description
The Endobronchial tube contians 1Pc Fr35 Right Endobronchial tube,1Pc Multifunctional joint and 2Pcs Fr10 Suction catheter, 1Pc Fr16Suction catheter.
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 complications during intub |
| 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 secure airway and will r |
| 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 as intended. |
| 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 catalog number 5-161 |
| 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 catalog number 5-161 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.