Every year, the Food and Drug Administration discovers new products with dangers attached. When you purchase a medical device at the recommendation of a doctor, you expect that that device is going to work well and help, not hurt you. The most vulnerable of all ill human beings may be newborn babies. In their first few days of life, these infants are often at risk to all sorts of illness. When a baby is born unhealthy, he or she is often quickly connected to machines to aid in breathing, feeding, and sustaining the infant’s life. With the right medical care, these machines and the doctors that operate them can help an infant to pull through dire circumstances and grow into a healthy child. However, if these machines don’t do their job, it can be the death of that child.
Recently, the Food and Drug Administration issued the recall of all CareFusion infant breathing machines. These breathing circuits were supposed to provide safe and clean oxygen to sick infants, but they weren’t doing their job. Due to sloppy assembly, the circuits could develop cracks, which cause leaks in the closed ventilation. This would cause the babies to inhale the non-ventilated air, and be at risk to germs and airborne illnesses. For an infant with a low immune system, this could be a fatal mistake. The breathing circuits have all been recalled, and CareFusion hopes to repossess all 280,000 of the products. These products were manufactured between June 1st, 2010 and February 3rd, 2012.
As of now, the FDA has not heard of any death reports from patients associating with the product. They hope that they caught the mistake in time to avoid any serious injuries or death from the medical product. CareFusion has since improved the way that they manufacture the circuits, and will make a stronger component that will not crack and endanger the babies. These new circuits are attachable and will link to a mechanical ventilator that can help the infants to breathe easier.
CareFusion is a company that cares about their product safety, which is why they requested that all hospitals using the AirLife Infant Breathing Circuit destroy or return the product immediately. They removed their product from the market. The FDA classified the recall as a Class I. This means that the mistake could cause serious health problems or death. This is the highest class of recall possible.
Below a Class I is a Class II, where the FDA declares that the product might cause a temporary health problem or pose a slight threat that could potential grow serious in time. For example, a defective medicine that simply does not cure its targeted illness, but does not issue side effects, would be a Class II recall. A Class III recall is one where the product is unlikely to provide any adverse effects, but violates FDA labeling or manufacturing regions. For example, if a candy bar forget to include an ingredient on their nutrition label, or miscalculated their calories, this would become a Class III recall.
As of right now, only half of the hospitals using CareFusion Infant Breathing Circuits have destroyed or returned their products. Doctors and nurses should say briefed on the product recalls that are issued each day by the FDA. By staying up-to-date they may be able to save lives, and steer clear of using medical products that will hurt, rather than help, their patients. If you or a loved one was injured or killed by a defective medical product, then you need to seek damages. Talk to a medical malpractice attorney to determine whether you should list the company that created the product as a defendant, or seek litigation against the hospital or doctor that made the mistake.