Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles (Two Class I Recalls)
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. These issues may lead to the decreased effectiveness of the port, replacement of the port, 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.
Recall Class: Class I
Date Recall Initiated: May 26, 2010
- 22 Gauge x 1 inch straight Huber needles
Model 10600218, Lot 9B020M.
- 22 Gauge Right Angle x 1 inch Huber needles
Model 10600219, Lot 9B017M
These products were not sold individually; they were sold to Navilyst and packaged in certain lots of Vaxcel Implantable Vascular Access Systems. The Navilyst vascular access systems containing these defective needles can be identified in the list below.
Navilyst Medical, Inc.*
- Certain lots of Vaxcel Implantable Vascular Access Systems with PASV (Pressure Activated Safety Valve) Technology
- Certain lots of Vaxcel Implantable Vascular Access Systems
* Navilyst Medical Inc. bought Boston Scientific Oncology Division in 2008; therefore, some recalled Vaxcel Implantable Vascular Access Systems are labeled as Boston Scientific products.
To find the complete list of products affected by this recall, see list below (Navilyst Medical, Inc. and Boston Scientific Vaxcel Implantable Vascular Access Systems Containing Huber Needles: Products Affected by the Class I Huber Needle Recall).
The affected devices were manufactured from May 2, 2007 to May 1, 2010 and were distributed from May 2, 2007 to May 1, 2010.
Huber needles are used to access ports implanted under the skin of patients. 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.
26 Victoria Ct.
Keene NH 03431
Navilyst Medical, Inc.
10 Glens Falls Technical Park
Glens Falls, New York 12801
Reason for Recall:
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.
Navilyst Medical Inc. may be contacted by phone at 1-800-833-9973, Monday through Friday, during the hours of 8:00 AM and 7:00 PM (Eastern Standard Time); and by FAX at 1-518-742-4450.
Multi-Med Inc. representative Susan Starkey can be contacted by phone at 1-603-357-8733, Monday through Friday, from 8:00 to 5:00 PM (Eastern Standard Time) for instructions for disposition of the needles.
FDA Districts: New York (Navilyst Medical, Inc.) and New England (Multi-Med, Inc.)
The company has advised:
- Immediately examine your inventory and quarantine product subject to therecall.
- Identify customers that have received these needles and notify them at once of this product recall.
- Immediately discontinue use of the product.
- If you must use the kit, consider using an alternative, unaffected non-coring needle if possible. However if you do not have an alternate and unaffected non-coring needle, consider performing the following flushing procedures of the port as recommended by the FDA:
- Avoid flushing the syringe when initially confirming needle 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 the silicone sliver. If the needle becomes clogged when attempting to aspirate, remove the needle, discard it and select a new one.
- Watch for signs and/or 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.
- Patients should continue to follow their doctor’s recommendations for receiving treatment.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
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.
- Information About Huber Needles
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
List of Affected Products: Navilyst Medical, Inc. Vaxcel Implantable Vascular Access Systems Containing Huber Needles: Products Affected by the Class I Huber Needle Recall. This list also includes those products labeled under Boston Scientific.
NAVILYST MEDICAL INC. PRODUCTS
BOSTON SCIENTIFIC PRODUCTS
|Product||Catalog Number||UPN Number||Lot Number|
|Vaxcel Port with PASV Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm)
|Vaxcel Port with PASV Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)
|Vaxcel Port with PASV Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
|Vaxcel Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm)
|Vaxcel Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm)
||45-310||M001453100||1273699 1285400 1286080 1287098|
|Vaxcel Port Titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm)
|Vaxel Port with PASV Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)
|Vaxcel Port with PASV Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
|Vaxcel Port w PASV Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)
|Vaxcel Port with PASV Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)
Made in the USA
Boston Scientific Corporation