FDA (Devices) recall action 94116
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Curaplex Nasal Intubation Kit recalled because the included endotracheal tube holder is incompatible with nasal intubation procedures, preventing practitioners from properly securing the tube.
Sarnova HC is recalling the Curaplex Nasal Intubation Kit because the endotracheal tube holder is incompatible with nasal intubation, preventing practitioners from securing the tube. The recall affects 550 units distributed nationwide.