Home › Device types › BTO
Tube, Tracheostomy (W/Wo Connector)
FDA product code BTO · Class 2 · Anesthesiology
3,486
Registered devices
6,588
Adverse events
73
Recalls
128
510(k) clearances
Devices with this code
Portex — ICU MEDICAL, INC.PILLING — TELEFLEX INCORPORATEDPILLING — TELEFLEX INCORPORATEDTRACOE comfort — Tracoe medical GmbHTRACOE mini — Tracoe medical GmbHTRACOE comfort — Tracoe medical GmbHTRACOE® comfort — Tracoe medical GmbHTRACOE® comfort — Tracoe medical GmbHPortex — ICU MEDICAL, INC.Portex — ICU MEDICAL, INC.Portex — ICU MEDICAL, INC.PILLING — TELEFLEX INCORPORATEDTRACOE comfort — Tracoe medical GmbHRadiopaque Standard Tracheal T-Tube — HOOD, E BENSON LABORATORIES INCSILVERVENT — Andreas Fahl Medizintechnik-Vertrieb GmbHChannick Y Stent — HOOD, E BENSON LABORATORIES INCPortex — ICU MEDICAL, INC.Portex — ICU MEDICAL, INC.Pertrach — ENGINEERED MEDICAL SYSTEMS INCIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONTRACOE® comfort — Tracoe medical GmbHTRACOE comfort — Tracoe medical GmbHTRACOE comfort — Tracoe medical GmbHMontgomery® Long-Term Cannula — Boston Medical Products, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-23 | Covidien LLC | Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. |
| 2024-06-07 | Smiths Medical ASD Inc. | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUper |
| 2024-06-07 | Smiths Medical ASD Inc. | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUper |
| 2024-06-07 | Smiths Medical ASD Inc. | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUper |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a |
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