LymeNet Flash: PORT (HUBER) NEEDLES - FDA RECALL (silicone slivers; leakage)

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»	LymeNet Flash » Questions and Discussion » Medical Questions » PORT (HUBER) NEEDLES - FDA RECALL (silicone slivers; leakage)

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Topic: PORT (HUBER) NEEDLES - FDA RECALL (silicone slivers; leakage)

Keebler
Honored Contributor (25K+ posts)
Member # 12673

posted

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http://www.cnn.com/2010/HEALTH/01/26/needles.recall/index.html?hpt=T2

FDA recalls more than 2 million needles used in port implants

By Saundra Young, CNN

January 26, 2010 3:59 p.m. EST

- Recall is a Class 1, denoting that the FDA considers the products to be of highest risk

Washington (CNN) --

Millions of needles used in ports implanted under the skin of chronically ill patients are being voluntarily recalled, the U.S. Food and Drug Administration announced Tuesday.

More than 2 million Huber needles, manufactured by Nipro Medical Corp. in Japan and distributed by Exelint International Corp., headquartered in Los Angeles, California, are affected.

Huber needles are used primarily in hospitals and clinics -- and in some instances by patients receiving long-term treatment at home -- to draw blood or to inject medicine, other nutritional solutions or blood products.

They are used with ports, which are small medical appliances placed under the skin.

The Class 1 recall -- denoting that the FDA considers the product to be of the highest risk -- involves Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint "Securetouch+" Safety Huber Infusion Sets.

. . .

Approximately 6 million Huber needles are used each year in the United States.

The agency determined that 60 to 70 percent of Exelint's needles "cored," or cut slivers of silicone, when inserted into ports, raising the possibility of the silicone slivers entering the veins, damaging the port itself or harming the surrounding tissue.

There have been reports of leakage, the FDA said, but none of silicone entering the vascular system as a result of the needles. It said anyone using the products should stop immediately and return any unused needles to Exelint.

. . . .

- full article at link above.

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