Recall of Exel Huber Needles―Dangerous Medical Product Could Release Silicone

Back in December 2009, the FDA announced a Class 1 recall—the highest risk category—of Exelint International needles sold under the name Exel Huber Needles, Exel Huber Infusion Sets, and Exel SecureTouch+ Safety Huber Infusion Sets.

The needles are used to inject various medications into ports implanted in a patient’s skin. These ports have silicon membranes to prevent leakage of medication or blood that the needle is pushed through. Huber needles are supposed to be designed to pierce the membrane without removing any of the silicon material.www.youtube.com/watch

The reason for the recall was that the defective needles malfunctioned in two different ways. The first way, where the needles leaked, was not harmful to any using the needles. However, the leaks did alert the FDA to possible problems with the Huber needles. When the FDA tested them, they found the needles "cored" in 60 to 72 percent of tests. “Coring” is what caused the ports to leak, but can also potentially allow silicone to enter a patient’s body when the port is initially accessed and flushed. Aside from decreased effectiveness because of the leaking, “coring” may cause infection, damage or death of tissue, swelling, or other serious adverse health consequences occurring as a result of the core travelling through blood vessels into the patient’s lungs. These issues may potentially cause death.

The coring problem is further exacerbated by the fact that the patients who use these silicone releasing needles are often immune-compromised or chronic pain sufferers. Therefore, adverse consequences from the effects of these defective needles may not be initially, if ever, reported!

More than 2 million of these needles were distributed nationwide and it is still unclear whether the recall efforts have been successful. As a San Francisco injury lawyer, I feel it is my duty to further publicize this recall and help to ensure that the most fragile people, who need these needles to begin with, are protected. If you have these needles, stop using them immediately. If you used these needles prior to the recall, make sure you discuss your concerns with your doctor to determine whether you could have been harmed by silicone released from these needles.

We are not representing any of the parties mentioned in this article at the time the article was posted. Our information source is cited in the article. If you used this product or a similar product and have questions as to your rights and options, call a reputable law firm. Do not act solely upon the information provided herein. Get a consultation. The best law firms will provide a free confidential consultation to consumers described in this article and their family members.