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

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.  

Affected Product

Product Names: Medline Kits Containing Medtronic Aortic Root Cannula, labeled as follows: 

• CABG OPNHRT SALEM HSP
• CARDIAC CABG  
• CARDIAC PACK  
• DR DANIELSON AC PACK  
• HEART BASIN PACK-LF  
• KARAS OH COMPONENT PACK  
• OPEN HEART ADULT PART 1 CDS  
• OPEN HEART B PACK-LF  
• OPEN HEART PACK  
• ZEESHAN OPEN HEART  
• TOL DR RIORDAN PACK  
• HEART BASIN PACK-LF 
• CPB ADJUNCT PACK  
• DR. CRESCENZO PACK  
• PK CUST CV A&B CABRINI CO  
• TOL DR RIORDAN PACK  
• TOL DR. CRESCENZO PACK  
• TOL DR. MORONT PACK

What to Do

On February 21, 2025, Medline Industries, LP sent all affected customers an Immediate Action Required Medical Device Recall notice recommending the following actions:  

• Complete the response form, listing all affected product in inventory.
  • Complete the form even if there is no affected product in inventory.
• Once completed, customers will receive labels for affected inventory that instruct staff to remove the recalled component before using the kit. 
• Notify any companies or individuals who may have received affected products. 

Reason for Correction

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

The use of 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 reported no serious injuries or deaths related to this issue.

Device Use

Medline medical procedure kits containing Medtronic Aortic Root Cannulas are convenience kits used for various medical procedures. The Medtronic Aortic Root Cannula in the kit is used for six hours or less during surgery with the heart-and-lung machine (cardiopulmonary bypass). The cannula may also be used to remove air from the major artery (aorta) when a bypass procedure is finished. 

Contact Information

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

Additional FDA Resources (listed in order of most to least recent):

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.