A Class I recall is the most serious type of recall. In a Class I recall, there is a reasonable chance that the product will cause serious health problems or death.
The FDA issued a Class I recall of the following huber needles:
- 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.
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
To find the complete list of products affected by this recall, click here. 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 FDA recommendation to clinicians/users:
- 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.