WASHINGTON – Federal health officials are announcing a recall of 2 million needles because of a risk they can push bits of silicone into patients' bodies.
The Food and Drug Administration said Miami-based Nipro Medical Corp. has voluntarily recalled its Exel/Exelint Huber needles manufactured between January 2007 and August 2009.
The needles are used to access injection ports, which are implanted under the skin of patients with chronic diseases who require frequent drug injections.
An ongoing FDA investigation found that the needles can dislodge bits of silicone from the ports, potentially pushing them into the patient's bloodstream.
An inspection at Nipro's manufacturing plant found that 60 to 72 percent of needles had the design problem.