Millions of Infusion Set Needles Recalled

More than two million infusion set needles are included in an urgent Class I recall today because the medical devices may have design and manufacturing defects that can endanger patients.

Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets, and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets manufactured by Nipro Medical Corporation for Exelint International Corporation are involved in the recall announced today by the Food and Drug Administration.

Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions, the FDA said. The needles are supposed to be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted.

Complaints Prompt Inpsections

However, inspections conducted late last year at Nipro facilities in Japan found that their needles “cored” in 60 to 72 percent of tests, the FDA said. Officials are continuing to investigate to determine why so many of the needles are failing to perform as designed. The inspections were conducted after some hospitals complained to the FDA that there was leakage between the access port and the Huber needle.

There have so far been no reports of any adverse events or injuries to patients associated with the defective infusion needle sets.

Dozens of Needle Models Recalled

The recalled needles were distributed nationwide and manufactured from January 2007 to August 2009. The units subject to the recall have a lot number that begins with “07,” “08,” “09,” and one of about two dozen product codes or catalog numbers. For a complete list of the infusion set needles involved in the product safety action, see the FDA’s recall notice.

Hospitals, clinics, and patients who have needles from these lists should immediately stop using them and return any unused products to Exelint International Corporation, the FDA said.

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