The FDA has issued a Class 1 recall of 2 million huber needles because of a coring problem resulting from defect in the manufacturing and design process. The huber needles are manufactured by Nipro Medical Corporation and distributed by Exelint International Corporation.
The FDA advises healthcare professionals to take the following precautions when using any type of Huber needle (ie, not just those manufactured by Nipro) in conjunction with normally operating ports:
* Avoid flushing the syringe when confirming patency of the needle on accessing the port, as it may introduce a silicone core into a patient’s body.
* Consider aspirating blood after accessing the port and then discard the syringe with its contents. This step may recapture the silicone sliver. If the needle becomes clogged, use a new one.
* Watch for indications of damage to the port’s septum. These include medication leakage, resulting in inadequate dosing as well as tissue damage, and localized erythema.
For detailed information about the recalled huber needles and lot numbers, click here.