FDA Announces Class I Recall of Infusion Needles Used in Treatment of Chronically Ill
Huber needles used in implanted ports to withdraw blood, inject medications, and other solutions
The U.S. Food and Drug Administration (FDA) announced a Class I recall of certain infusion set needles used in the treatment of chronically ill patients and others. Products included in the recall are the following all manufactured by the Japan-based Nipro Medical Corporation for Exelint International Corporation.
Exel/Exelint Huber needles
Exel/Exelint Huber Infusion Sets
Exel/Exelint “Suretouch+ [plus.”
The recall comes in response to inspections of Japanese Nipro facilities carried out in October 2009. These inspections found that the needles, used to access under skin ports designed for repeated access to veins, “cored” in approximately 60 to 72 percent of tests. According to the FDA, coring means that the silicone cores (or silvers) of the needles were cutting and dislodging the under skin ports when inserted, causing the ports to leak in certain cases.
In a news release about the recall, the FDA stated that:
“At this time, the FDA has not received any adverse event reports related to silicone foreign bodies released in patients from Huber needle coring. The agency received only reports of port leakage. However, because it may be very difficult for clinicians to associate adverse patient outcomes with the use of defective Huber needles, there may be under-reporting of events.”
Needles involved in the recall were manufactured between January 2007 and August 2009. According to the FDA, this recall includes more than 2 million units in distribution nationwide.
The affected needles have lot numbers beginning with the following, along with a catalogue number of product code:
“07”
“08”
“09”
For more information, please read the following articles on the Class I FDA recall for Needles
FDA’s New Release about Recall: FDA Announces Class I Recall of Certain Infusion Set Needles
CNN Health Article on Recall: FDA recalls more than 2 million needles used in port implants
