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The FDA Issues Class 1 Recall on Needles

By Admin on January 27, 2010 | Last updated on March 21, 2019

The FDA issued a Class 1 recall on needles manufactured by Huber. While the company is headquartered in Los Angeles, the needles involved in this recall were made in Japan. According to a press release by the FDA, the needles were 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. They designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted.

However, CNN reports that after an investigation by the FDA, the needles were found to cut slivers of silicone when inserted into ports, which raised the possibility of the silicone slivers entering the veins, damaging the port itself, or harming the surrounding tissue in patient. This occurred in 60-70% of the needles made by Huber. The press release by the FDA indicates that over 2 million needles are affected by this recall. The needles that are being recalled were manufactured from January 2007 to August 2009.

There are currently ongoing investigations on 20 companies that manufacture needles. To date, only 10 investigations have been completed. No other products have been recalled.

All hospitals, clinics and patients who have needles from these lists should immediately stop using these affected products and return any unused products to Exelint International Corporation. Direct all questions concerning this recall to:

Attn: Armand Hamid
EXEL International
5408 West Centinela Ave
Los Angeles, Calif. 90045-1504
Tel. 800-940-3935
Fax 800-308-5048
E-mail: info@exelint.com

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