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Total Control Introducer™ (TCI)
Through The Cords, LLC · Model 000163 · UDI-DI 00860581002639
BSR
Prescription
10
510(k) clearances
507
Adverse events (10 deaths)
16
Recalls
135
Facilities
Description
Articulating Introducer with detachable handle, intuitive depth system, 70 CM, 15 Fr, latex free, single use, sterile, fits 6.0 and larger ID tubes
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 the end cap and the tu |
| 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 the end cap and the tu |
| 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 the end cap and the tu |
| 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 breach in the steri |
| 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 breach in the steri |
| 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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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.