MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C P…

Recall date

February 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1459-2025

FDA classification

Class I

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

US: CA, FL, MN, NY, OH, OR, PA, TX, WV

Why it was recalled

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.