FDA-Device2025-04-16Class I

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.

MEDLINE INDUSTRIES, LP - Northfield
Hazard

Medline medical procedure kits, containing Medtronic Aortic Root Cannula

Sold states
US: CA, FL, MN, NY, OH, OR, PA, TX, WV
Affected count
1310 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1456-2025

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