FDA has put out a Class 1 recall of certain lots of Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes.
A Class I recall is one of the most serious types of recalls. It tends to involve circumstances where there is a likelihood that use of this product will cause death or serious adverse health problems.
The Smiths Medical Bovina Neonatal, Pediatric and Flextend Tracheostomy Tube is made for use after a tracheostomy. This surgery creates an opening in the trachea to aide patients breathe after undergoing surgery, or when there may be a blockage in the airway. Smiths Medical Bovina Neonatal, Pediatric and Flextend Tracheostomy Tubes are used to help keep the opening clear and clean.
Patients and health-care providers that have used or prescribed Smiths Medical Bovina Neonatal, Pediatric and Flextend Tracheostomy Tubes are being alerted that a recall has been made as some patients have had problems when disconnecting the kit from connectors of affected tubes. Patients also indicate that they are unable to disconnect the device or were required to use excessive force to remove the tube. It is a life threatening situation if the tube is accidentally pulled out. Emergency intervention by an expert may be required to reinsert the tube.
The Bovina Pediatric, Neonatal and Flextend tracheostomy tube is used to deliver airway access for a tracheostomized patient for upwards of 29 days. This product is primarily used in various health care facilities as well as home care environments. The affected recalled product Lot Numbers are from 1631477 through 1923406. These recalled Smiths Medical Bovina Neonatal, Pediatric and Flextend Tracheostomy Tubes were manufactured from August 29, 2009 to January 29, 2011.
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If you, a friend or family member, have been affected by a Smiths Medical Bovina Neonatal, Pediatric and Flextend Tracheostomy Tube please contact our office today. For more information please contact Bernheim & Dolinsky, L.L.C. at 1-800-474-4089 or contact us online.
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