Nipro Med Corp recalls 2 million medical needles in U.S.

A subsidiary of the Japanese company Nipro Corp, Nipro Medical Corporation, Miami FL, is initiating 2 nationwide recalls of syringes manufactured by them. The first is of all GlucoPro Insulin Syringes and was initiated on January 21, 2010. According to the FDA, these syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection.

This recall includes all product codes and lot numbers with expiration dates before 2011-11 (Nov 1, 2011):
Product Code Lot # Expiry date
JD+01U3008-5C A08022 2011-11
JD+01U3013-5C A08013 2011-06
JD+01U3013-5C A08017 2011-08
JD+01U3108-5C A08013 2011-06
JD+01U3108-5C A08017 2011-08
JD+03U3008-5C C08022 2011-11
JD+03U3013-5C C08013 2011-06
JD+03U3013-5C C08017 2011-08
JD+03U3108-5C C08013 2011-06
JD+03U3108-5C C08017 2011-08
JD+05U3008-5C B08022 2011-11
JD+05U3013-5C B08013 2011-06
JD+05U3013-5C B08017 2011-08
JD+05U3108-5C B08013 2011-06
JD+05U3108-5C B08017 2011-08

The second is a Class I recall of 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. This includes 2 million Huber infusion set needles distributed in the United States. An October 2009 inspections of Nipro facilities by the FDA found problems with the needles that could allow pieces of the port's silicone core to become dislodged. The inspections found around 60-72% of Nipro's needles tested had this problem.

The needles are used for special medical purposes including accessing ports implanted under the skin of chronically ill patients for repeated access to veins, withdrawing blood, and injecting medicines. These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted. The needles were distributed by privately held Exel International from Los Angeles. As of now, no injuries have been reported, FDA officials noted that they were concerned a piece of silicone could enter a patient's bloodstream.

Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with “07,” “08,” “09,” and one of the following product codes or catalog numbers:

Exel/Exelint Huber Needles Product Codes/Catalog Numbers:
26901
26902
26904
26906
26907
26908
26909
26911
26921
26922
26923
26924
26925

Exel/Exelint Huber Infusion Sets Product Codes/Catalog Numbers With/Injection Site:
27940R
27941R
27944R
27945R
27946R
27948R
27949R
27950R

Without/Injection Site Product Codes/Catalog Numbers:
27954R
27955R
27958R
27959R
Exel/Exelint “SecureTouch +” Safety Huber Sets Product Codes/Catalog Numbers:
37854S
37855S
37858S

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. The FDA has issued a letter to manufacturers of other Huber needles to address design and manufacturing concerns.

Further Details @ FDA.gov