AngioDynamics recalls dialysis catheterThursday July 10, 6:00 pm ET
AngioDynamics recalls dialysis catheter because of manufacturing problem
QUEENSBURY, N.Y. (AP) -- Medical device maker AngioDynamics Inc. said Thursday it is recalling its Centros dialysis catheter because of a suspected manufacturing issue.
The cuff on the device, which is used to anchor the catheter during dialysis procedures, was inadequately attached in some instances, the company said. That allowed the entire catheter to move, caused leakage around the site, or left the cuff inside the insertion site when the catheter was removed in some cases.
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The cause of the problem is likely due to a manufacturing production issue, the company said, and the recall is voluntary.
"Pending the U.S. Food and Drug Administration review, shipments of Centros are expected to resume during the company's fiscal third quarter, which begins Dec. 1, 2008," the company said in a statement.
AngioDynamics has shipped about 1,500 Centros catheters as part of a limited launch since January. The number of instances reported to date amount to fewer than 1 percent of those shipped products, it added. Costs associated with the recall will likely be minimal, it said.
Physicians, hospitals and patients with product related questions may call AngioDynamics Customer Service at 1-800-772-6446.
Shares of AngioDynamics rose 23 cents to close at $13.58.
http://biz.yahoo.com/ap/080710/angiodynamics_recall.html?.v=1
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