WASHINGTON - Federal health officials announced the recall of 2 million medical needles yesterday because of a risk they can push bits of silicone into patients’ bodies.
The Food and Drug Administration said Japanese manufacturer 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 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.
However, an FDA investigation found that the needles can dislodge bits of silicone from the ports, potentially pushing them into the patient’s bloodstream.
FDA officials told reporters they are working with 19 other manufacturers to determine if their needles have the same problem. The agency estimates 6 million Huber needles are sold in the United States each year.
According to FDA regulatory specialist Mary Brooks, there have been no reports of silicone shards in patients.
This was the second recall from Nipro in a week. On Thursday the company recalled 15 lots of GlucoPro Insulin Syringes.