FDA Announces Recall of 2M Defective Needles
Federal health officials announced the recall of 2 million medical needles last month because of a risk they can push bits of silicone into patients’ bodies. According to an article on Philly.com, the Food and Drug Administration (FDA) said Nipro Medical Corp. voluntarily recalled its Exel/Exelint Huber needles manufactured between January 2007 and August 2009.
The needles are used to access injection ports, which are devices implanted beneath the skin of patients who require frequent injections. The ports connect to a vein and allow easy delivery of chemotherapy, antibiotics, and other injectable drugs.
Huber needles are designed to be non-coring, or to penetrate an injected material without retaining any of it.
However, an FDA investigation found that the needles could dislodge bits of silicone from the ports, potentially pushing them into the patient’s bloodstream. The problem can also damage the ports themselves, resulting in problems delivering drug therapy.
According to the FDA, 60 to 72 % of the company’s needles had the design problem.
The FDA is working with 19 other manufacturers to determine if their needles have the same problem.
Doctors may have difficulty identifying the problem of silicone shards in patients. The FDA recommended that physicians watch for signs of tissue or nerve damage in patients, which could be a sign of damage to their port. And, they suggested throwing out the first syringe injected into a port, in an effort to discard any bits of silicone.
Consumers have the right to assume that products they purchase or use have been produced in a manner that would ensure that they are safe and free from unreasonable risks. If a company manufactures a product that is hazardous to the user, the company must be held liable for any injuries or fatalities that occurred due to the faulty product.
There are innumerable products that may pose serious threats to innocent consumers if they have a defect, and may include auto parts, toys, medications, motor vehicles, household appliances, and furniture.
If you have a Pennsylvania defective product claim, you will require the representation of a Philadelphia Pennsylvania products liability attorney from Cherry, Fieger and Marciano, LLP to handle all of the complexities involved with this type of case. There are many steps to a product liability case, beginning with proving that the product was in fact defective, next proving the product was the cause of the injury, and finally proving that the product was not used unreasonably. Contact their firm today to discuss your case with an experienced legal professional.
Source article: http://www.philly.com/philly/business/20100126_ap_fdaannouncesrecallof2mdefectiveneedles.html
