Huber Needles: Recall - Risk of Coring
MedSun: Newsletter #54, November 2010

FDA MedWatch Safety Alert

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. 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.

For more information about FDA’s safety investigation of Non-Coring (Huber) Needles, please visit the website provided under Additional Information below.

Additional Information:

FDA MedWatch Safety Alert. Huber Needles: Recall - Risk of Coring. October 15, 2010.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm229068.htm

Safety Investigation of Non-Coring (Huber) Needles: Updated October 25, 2010. FDA Medical Device Safety.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm198766.htm


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