FDA Issues 2 Recalls of Huber Needles

Emma Hitt, PhD

Disclosures

August 27, 2010

August 27, 2010 — The US Food and Drug Administration (FDA) has issued 2 class 1 recalls of Huber needles due to cases of coring when inserted into ports. "Coring may lead to infection, damage or death of tissue, swelling, or other serious adverse health consequences, occurring as a result of the core travelling through blood vessels into the patient's lungs. These issues may potentially cause death," the FDA announced.

The recalls include certain models and lot numbers of 22 Gauge x 1" straight Huber needles and 22 Gauge Right Angle x 1" Huber needles. The needles were distributed by Navilyst as a component of Vaxel Implantable Port Systems, some of which may have Boston Scientific labeling. A full list of the product codes and lots numbers subject to the recalls is available at on the FDA's Web site.

According to the FDA, more than 54,000 units distributed between May 2, 2007, and May 1, 2010, are included in the recalls. An alert was issued yesterday as a part of an ongoing investigation after testing in September and November 2009 detected cores in 2 lots of Multi-Med needles. Cores were seen in an estimated 23% to 86% of the sample lots.

The FDA recommends that flushing of the syringe should be avoided when initially confirming needle patency upon accessing the port. "If the needle has cored the port, flushing may introduce the core into the patient's body, and could lead to serious adverse events."

When possible, upon accessing the port, aspiration of a small amount of blood from the port after septum puncture should be considered and then the syringe should be discarded with its contents. "This step may recapture the silicone sliver. If the needle becomes clogged when attempting to aspirate, remove the needle, discard it and select a new one," according to the FDA alert.

Healthcare professionals should also watch for signs and/or symptoms that may indicate damage to the port's septum, such as "medication leakage resulting in inadequate therapy delivery, along with tissue, nerve and/or muscle damage; and redness of the surrounding area."

The current recalls follow a previous class 1 recall of 2 million Huber needles manufactured by Nipro Medical Corporation and distributed by Exelint International Corporation announced on January 26, 2010.

Huber needles are used to access ports subcutaneously for repeated access to veins for the withdrawal of blood and infusion of fluids. The FDA suggests that it may be difficult for clinicians to associate adverse patient outcomes with the use of defective Huber needles, and adverse events may be underreported.

Facilities that have products affected by the recall should immediately discontinue the use of the needles and return unused product to the manufacturer. Navilyst Medical, Inc, may be contacted at 800-833-9973 between 8:30 AM and 7:00 PM Eastern Standard Time and by fax at 518-742-4450.

To report adverse events related to Huber needles, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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