[pending] Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEA
Pending LLM rewrite. Source: FDA_DEVICE Z-1458-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- HEART BASIN PACK-LF
- UDI/DI 10195327563561 (ea) 40195327563562 (case)
- Lot Numbers 24BMB798
- 24DMH381
- 24EMF949
- 24GMF161
- 24IMB237.
Distribution
Distributed in 9 states:
- CA
- FL
- MN
- NY
- OH
- OR
- PA
- TX
- WV
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