Medical device recalls High risk

MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIA…

Recall date
February 21, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1456-2025
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

Medline medical procedure kits, containing Medtronic Aortic Root 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: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.

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