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Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Procedure Kits Containing Medtronic Aortic Root Cannulas Due to Potential Excess Material in Male Luers

Medline Industries LP is correcting certain lots of their medical procedure kits containing recalled Medtronic Aortic Root Cannulas due to potential excess material in the male luers. Medline is providing a sticker to adhere to the procedure kits notifying the user not to use the aortic root cannula within the procedure kit and use an aortic root cannula from another supplier.

Using the affected products may cause serious adverse health consequences, including procedure delay, neurological deficits/stroke (reversable and irreversible), and death.  

At this time, Medline Industries, LP has not reported any serious injuries or deaths related to this issue.

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Questions?

Customers in the U.S. with questions about this recall should contact the Recall Department at 866-359-1704 or recalls@medline.com.