Two Class I Recalls for Huber Needles

Multi-Med, Inc. has issued a recall of its <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">22-Gauge x 1-inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., has recalled its <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">Vaxcel Implantable Vascular Access Systems Containing Huber Needles, the U.S. Food and Drug Administration (FDA) just announced. This represents two Class I recalls, which are the most serious type and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

In September and November 2009, FDA sampled and tested Navilyst Medical, Inc. products containing Huber-style needles manufactured by Multi-Med, Inc. FDA testing determined that these needles “cored” in 23 to 86 percent of tests.

Huber needles are used to access ports implanted under the skin of patients in need of repeated intravenous therapy. These needles are intended to penetrate the port septum without cutting or dislodging any silicone cores (or slivers) from the ports into which they are inserted.

A “coring” Huber needle could damage the implanted port by removing silicone slivers from the access membrane. The defect in the port as a result of coring can cause the ports to leak. The core can also potentially enter a patient’s body when the port is initially accessed if it is not flushed correctly. These issues may lead to decreased port efficacy, port replacement, infection, damage or death of tissue, swelling, or other serious adverse health consequences due to the core traveling through blood vessels into the patient’s lungs. These issues may potentially cause death.

Model and lot information the Humber needles follow. Of note, these products were not sold individually; they were sold to Navilyst and packaged in certain lots of Vaxcel Implantable Vascular Access Systems: 22 Gauge x 1 inch straight Huber needles: Model 10600218, Lot 9B020M and 22 Gauge Right Angle x 1 inch Huber needles: Model: 10600219, Lot 9B017M

The Navilyst vascular access systems containing these defective needles are manufactured by Navilyst Medical, Inc. and include the following. Navilyst Medical Inc. bought Boston Scientific Oncology Division in 2008; therefore, some recalled Vaxcel Implantable Vascular Access Systems are labeled as Boston Scientific products: Certain lots of Vaxcel Implantable Vascular Access Systems with PASV (Pressure Activated Safety Valve) Technology and Certain lots of Vaxcel Implantable Vascular Access Systems.

A complete list of products affected by this recall can be accessed on the FDA’s website at: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm224068.htm

The affected devices were manufactured from May 2, 2007 to May 1, 2010 and were distributed from May 2, 2007 to May 1, 2010. The recalling firms are Multi-Med, Inc., 
26 Victoria Court, Keene, New Hampshire, 03431 and Navilyst Medical, Inc., 
10 Glens Falls, Technical Park, 
Glens Falls, New York, 12801

Distributors are advised to immediately examine inventory and quarantine product subject to the recall and identify customers who have received these needles and notify them at once of this product recall. Patients should continue to follow their doctor’s recommendations for receiving treatment.

Clinicians/Users are urged to immediately discontinue use of the recalled product. If the kit must be used, consider an alternative, unaffected non-coring needle, if possible. If no viable alternative exists and no unaffected non-coring needle is available, consider the FDA’s port flushing procedures at: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm224068.htm

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by FAX.