Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles
Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles
Infusion Set Needles [Manufactured by Nipro for Exelint]
AUDIENCE: Risk Manager, Surgery, Critical Care Medicine
ISSUE: FDA notified healthcare professionals of the Class I Recall of certain Huber needles that were determined by FDA testing to produce cores when inserted into ports. Coring may lead to infection, damage or death of tissue, swelling, or other serious adverse health consequences, occurring as a result of the core travelling through blood vessels into the patient’s lungs. These issues may potentially cause death.
BACKGROUND: Following hospital reports to the FDA of leakage after accessing the port with a Huber needle (labeled to be non-coring), FDA conducted its own laboratory testing of Huber needles from multiple manufacturers. Huber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. 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.
RECOMMENDATION: Clinicians should immediately discontinue use of the recalled products. If you must use the kit, consider using an alternative, unaffected non-coring needle if possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/26/2010 - Recall Notice - FDA]
Previous MedWatch Alert:
[01/26/2010 - Recall Notice - FDA]