FDA-Device2025-04-16Class I

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.

MEDLINE INDUSTRIES, LP - Northfield
Hazard

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.

Sold states
US: CA, FL, MN, NY, OH, OR, PA, TX, WV
Affected count
1247 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: 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1459-2025

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