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Stylet, Tracheal Tube
FDA product code BSR · Class 1 · Anesthesiology
217
Registered devices
506
Adverse events
16
Recalls
32
510(k) clearances
Devices with this code
Runnels Steerable Introducer™ DLT (35F/37F) — Through The Cords, LLCSHERIDAN — TELEFLEX INCORPORATEDSunMed — SUNMED, LLCCARDINAL HEALTH — Cardinal Health 200, LLCRUSCH — TELEFLEX INCORPORATEDAincA® — ANESTHESIA ASSOCIATES, INC.Medline — MEDLINE INDUSTRIES, INC.n.a. — VBM Medizintechnik GmbHSourceMark — SOURCEMARK, LLC.ProVu Video Stylet — FLEXICARE MEDICAL LIMITEDSHERIDAN — TELEFLEX INCORPORATEDVital Signs™ — AIRLIFEUSB™ UNIVERSAL STYLET BOUGIE 15FR OD 5.0 MM — Intersurgical IncorporatedIntubating Stylet OD 4.0mm (12Ch) 405mm — FLEXICARE MEDICAL LIMITEDAnesthesia — SUNSET HEALTHCARE SOLUTIONS, INC.Runnels Steerable Introducer™ #3 Oral/Nasal — Through The Cords, LLCVYGON — VYGONPortex — ICU MEDICAL, INC.SunMed — SUNMED, LLCHUDSON RCI — TELEFLEX INCORPORATEDSunMed — SUNMED, LLCHUDSON RCI — TELEFLEX INCORPORATEDSHERIDAN — TELEFLEX INCORPORATEDQuickSteer Introducer — Tjb Medical, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-28 | Smiths Medical ASD, Inc. | Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between th |
| 2024-10-28 | Smiths Medical ASD, Inc. | Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between th |
| 2024-10-28 | Smiths Medical ASD, Inc. | Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between th |
| 2017-05-11 | Teleflex Medical | Product size listed on the labeling is incorrect. |
| 2016-08-19 | Brathwaites Oliver Medical | The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation. |
| 2015-08-24 | Teleflex Medical | Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. |
| 2015-08-24 | Teleflex Medical | Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. |
| 2015-03-13 | Vital Signs Colorado Inc. | Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a |
| 2015-03-13 | Vital Signs Colorado Inc. | Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a |
| 2014-12-23 | Cardinal Health | A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube. |
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