Micromedics Inc. has issued a Class 1 recall for its surgical sealant dispensers, nasal septal buttons, and its otological ventilation tubes. A Class 1 recall is considered by the FDA the most serious type of recall because the product in question may cause severe injury or death.
The medical products were recalled because of weak or open seals, which may lead to contamination. Micromedics’ surgical sealant dispenser is used for the application of two liquids. The nasal septal button is employed for the nonsurgical closure of an opening in the nasal septum. The otological ventilation tubes are used to repair a chronic failure of the Eustachian tube which connects the middle ear to the nose.
These products were sold from February 15, 2010 until March 4, 2010 a few weeks before the recalls were issued.
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