A Class 1 recall, the U.S. Food and Drug Administrationâ€™s (FDA) most severe, has been issued for Micromedics, Inc. <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes. According to the FDA, the recall was issued due to weak or open seals.
These medical products are contained in sterile pouches that have weak or open seals. These products could become, or have been, contaminated due to compromise in sterility. This can cause serious adverse health consequences and/or death. The firm issued the recall on March 15, 2010. These products were distributed from February 15, 2010 through March 4, 2010.
The use of these productsâ€”Surgical Sealant Dispenser: Instrument for the application of two liquids;â€¨Micromedics Nasal Septal Button: Used for nonsurgical closure of an opening in the septum of the nose; andâ€¨Otological Ventilation Tubes: Implants designed to provide ventilation to the middle ear space through the eardrum (tympanic membrane)â€”occurs when there is there is a chronic failure of the tube that connects the middle ear to the nose (Eustachian tube) and when the problem does not respond to conventional therapy.
For specific model and lots numbers please view the Medical Device Recall at: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm234562.htm
Customers are advised to contact the firm to return any affected product for replacement at 1-800-624-5662 or 651-452-1977 ext. 224, Monday- Friday, 7:30 a.m. to 5:00 p.m., Central Time.
Help filing claims and other legal assistance for the victims of defective medical devices, including Micromedicsâ€™ Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes, is available at <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">www.yourlawyer.com.