Image via WikipediaThe US Food and Drug Administration (FDA) has issued 2 class 1 recalls of Huber needles due to cases of coring when inserted into ports. "Coring may lead to 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 FDA announced.
The recalls include certain models and lot numbers of 22 Gauge x 1" straight Huber needles and 22 Gauge Right Angle x 1" Huber needles. The needles were distributed by Navilyst as a component of Vaxel Implantable Port Systems, some of which may have Boston Scientific labeling. A full list of the product codes and lots numbers subject to the recalls is available at on the FDA's Web site.
According to the FDA, more than 54,000 units distributed between May 2, 2007, and May 1, 2010, are included in the recalls. An alert was issued yesterday as a part of an ongoing investigation after testing in September and November 2009 detected cores in 2 lots of Multi-Med needles. Cores were seen in an estimated 23% to 86% of the sample lots.