FDA (Devices) recall action 71197
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.
Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.
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.
FDA recalls Shiley tracheostomy tubes due to reports of patient discomfort and breathing difficulties.
FDA is recalling Shiley Neonatal and Pediatric Tracheostomy Tubes because patients reported discomfort and breathing difficulties after switching to these products.