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UE Intubation Stylet
Zhejiang UE Medical Corp · Model P2 · UDI-DI 06970283489424
BSR
Prescription
10
510(k) clearances
506
Adverse events (10 deaths)
16
Recalls
135
Facilities
Description
The device is intended to introduce devices into cavity or tissue.
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.