The FDA recently designated three medical devices made by CareFusion, Johnson & Johnson, and Teleflex as Class 1, meaning that there exists a reasonable probability that the use of or exposure to the devices will cause serious adverse health effects or possibly death. The CareFusion Alaris Syringe Pump, Johnson & Johnson’s Ethicon Endo-Surgery unit, and Teleflex Medical’s endobronchial tubes have all received the Class 1 designation and will be recalled.
CareFusion Alaris Syringe Pump
This recall is CareFusion’s ninth Class 1 recall since 2010. The Alaris Syringe Pump device has been recalled many times for a variety of flaws, which have included a faulty alarm system causing pump shutoff and tendency for the device to administer incorrect quantities of fluid, leading to severe injury or death. Nearly 1,000 units will be recalled due to the latter defect.
Johnson & Johnson Ethicon Endo-Surgery Unit
An issue with the Sedasys Computer Assisted Personalized Sedation System has caused the recall of Johnson & Johnson’s Ethicon Endo-Surgery Unit. So far, 14 units of the device in four states have been affected by the defect. According to the FDA’s recall database, disinfecting methods that were not specified in the usage instruction have caused a breakdown of the unit’s plastic material.
Teleflex Medical Endobronchial Tubes
Teleflex medical is faced with the recall of nearly 189,000 defective endobronchial tubes. These tubes, which are inserted through the mouth and into the lungs during bronchospirometry procedures, may leak oxygen, causing respiratory distress by not delivering enough oxygen to the patient. Specifically, the issue lies in the double swivel connector, which may separate or break from the tube.
The recall information is available from the FDA database, and the companies have sent communications to consumers specifying action to be taken.
What to do if You’re Injured by a Defective Device
The Florida Law Group has over 100 years of combined experience fighting for the rights of personal injury victims, including those who have suffered from defective medical devices. If you have been injured or have suffered the loss of a loved one, please call a Tampa product liability lawyer from our firm for a free consultation to learn how we can help you obtain financial compensation. Call today: (833) 899-0310.