FDA (Devices) recall action 94852
The FDA (Devices) publishes a recall like this one as 28 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 28 pages.
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
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.
Smiths Medical recalls specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes due to manufacturing defects in the securement flange that may tear.
Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected lots include neonatal, pediatric, and adult sizes distributed worldwide with 177,340 units impacted.
Smiths Medical recalls specific lots of Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes worldwide due to a manufacturing defect that may cause the securement flange to tear.