Nipro Medical Corporation is in the news again – this time for a class 1 recall of 2 million Huber needles due to a coring defect related to design and manufacturing processes. The U.S. Food and Drug Administration announced the recall of these needles on January 26, 2010.

The needles affected by the recall include Exel/Exelint Huber needs, Exel/Exelint Huber infusion sets, and Exel/Exelint Securetouch+ safety Huber infusion sets. The recalled needles were manufactured from January 2007 to August 2009 and begin with the lot numbers 07, 08, and 09. For a list of the product codes and catalog numbers subject to recall, visit the FDA news release. 

Huber needles are used to access ports implanted under the skin of chronically ill patients who need repeated access to veins for blood draws and infusion of medications, nutritional solutions, blood products, and contrast for imaging studies. These needles should be designed to penetrate the port without cutting or dislodging any silicone cores from the ports into which they are inserted. Inspections of Nipro facilities conducted in October 2009 revealed that their Huber needles ‘cored’ in 60 to 72 percent of tests. At this time, only needles manufactured by Nipro have shown a high frequency for coring, but the FDA is continuing its investigation and will update the public with any new developments.

A class 1 level recall is the strongest recall level issued by the FDA. So far, the FDA has not received any adverse event reports related to silicone foreign bodies released in patients from coring of the Huber needles. The only reports received have been regarding port leakage. The FDA is also working closely with all 20 manufacturers of Huber needles in order to understand the possible reasons for coring and to identify corrective measures. Healthcare professionals are advised to take precautions when using Huber needles; for more information, visit the FDA website.

Source:

FDA News Release 26 January 2010.

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