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Stylet, Tracheal Tube
FDA product code BSR · Class 1 · Anesthesiology
224
Registered devices
513
Adverse events
16
Recalls
32
510(k) clearances
Devices with this code
SunMed — SUNMED, LLCIntubating Stylet OD 5.0mm (15Ch) 700mm — FLEXICARE MEDICAL LIMITEDSourceMark — SOURCEMARK, LLC.Endure — ENDURE INDUSTRIESSunMed — SUNMED, LLCPortex — ICU MEDICAL, INC.X-Changer — VBM Medizintechnik GmbHn.a. — VBM Medizintechnik GmbHBougie / Introducer OD 5.0mm (15Ch) 700mm — FLEXICARE MEDICAL LIMITEDVital Signs™ — AIRLIFEResp-O2 Intubating Stylette, 14 FR — Dynarex CorporationSunMed — SUNMED, LLCSunMed — SUNMED, LLCVYGON — VYGONn.a. — VBM Medizintechnik GmbHRUSCH — TELEFLEX INCORPORATEDMedline — MEDLINE INDUSTRIES, INC.Runnels Steerable Introducer™ #5 Nasal — Through The Cords, LLCBougie Stylet — Wm & Dg, Inc.Resp-O2 Intubating Stylette, 6FR — Dynarex CorporationStylet – Tracheal Tube/ Bougie Catheter — GMMI SDN. BHD.Ambu® SureSight TM Stylet; small — VBM Medizintechnik GmbHMallinckrodt — Covidien LPHUDSON RCI — TELEFLEX INCORPORATED
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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