Insulin syringes and Huber infusion needles distributed by Nipro Medical Corp. are being recalled in two separate actions involving millions of units.
On Jan. 21, the Miami-based company voluntarily recalled all GlucoPro insulin syringes(www.fda.gov) with product codes and lot numbers that expire before November 2011.
The affected product code/lot number combinations are
- JD+05U3108-5C/B08013 and
The recall does not include GlucoPro syringes used with the company's Amigo Insulin Pump.
Nipro Medical Corp., which is a wholly owned U.S. subsidiary of Osaka, Japan-based device manufacturer Nipro Corp., said no injuries associated with the defect have been reported to date, but the syringes may have needles that detach. The defect could cause the needle to become stuck in the insulin vial, push back into the syringe or remain in the user's skin after injection.
A similar problem led Qualitest Pharmaceuticals Inc., of Huntsville, Ala., to recall millions of its Accusure insulin syringes in October.
Consumers who have GlucoPro insulin syringes should stop using them and return them to the point of sale for a refund, Nipro said. Consumers with questions may contact the company at (305) 599-7174, Ext. 249.
In an unrelated action, on Jan. 26, the FDA announced the recall of more than 2 million Huber needles manufactured by Nipro Corp. for Exelint International Corp.
Huber needles are used to access ports implanted under the skin of chronically ill patients to withdraw blood or inject medications and other solutions. FDA officials said in a news release(www.fda.gov) that Huber needles should penetrate ports without cutting and dislodging any silicone cores. However, the agency said, Nipro's Huber needles "cored" in at least 60 percent of tests conducted last October at Nipro Corp.'s facilities in Japan. The FDA is continuing its investigation into the cause of the problem, which is thought to be related to design and manufacturing processes.
The regulatory action was made as a Class I recall(www.fda.gov), which means "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death," said FDA officials.
The recall involves Exel/Exelint Huber needles(www.accessdata.fda.gov), Exel/Exelint Huber Infusion Sets(www.accessdata.fda.gov) and Exel/Exelint SecureTouch+ Safety Huber Infusion Sets(www.accessdata.fda.gov) manufactured from January 2007 to August 2009. Units subject to recall have lot numbers that begin with "07," "08" or "09." Complete lists of the affected product codes and catalog numbers are available online.
Hospitals, clinics and patients who have affected needles in stock should stop using them and return unused products to Exelint, the FDA said. The Culver City, Calif.-based company may be contacted by phone at (800) 940-3935 or by e-mail.
FDA officials said they have received no adverse event reports related to silicone foreign bodies released in patients as a result of coring to date. The agency said it is working with all 20 manufacturers of Huber needles to understand the potential causes for coring and identify corrective measures.
The FDA recommends that health care professionals consider taking the following precautions when accessing implanted ports with Huber needles:
- Avoid flushing the syringe when initially confirming the needle's 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, consider aspirating a small amount of blood from the port after septum puncture, then discard the syringe with its contents. This step may recapture any silicone sliver that may have been introduced. If the needle becomes clogged when attempting to aspirate, remove the needle, discard it and select a new one.
- Watch for signs and 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.
Health care professionals and consumers should report serious adverse events or product quality problems(www.fda.gov) associated with the use of Huber needles or GlucoPro Insulin Syringes to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.