FDA recall Z-1458-2025

MEDLINE INDUSTRIES, LP - Northfield · Class I · device

Product

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF

Reason for recall

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2025-02-21
Report date: 2025-04-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1458-2025