Medline Heart Basin Procedure Kits with Aortic Cannula Recalled
Medline medical procedure kits containing Medtronic Aortic Root Cannula are recalled due to potential excess material in the male luer connectors on the aortic cannula.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I for a medical device (aortic cannula used in cardiac procedures), which per the rubric requires a minimum score of 4. No reported illnesses or injuries are stated in the source, but the potential for excess material in luer connectors on a critical cardiac device presents significant risk of harm.
Plain-English summary
Medline Industries is recalling 320 units of Heart Basin Pack-LF procedure kits that contain a Medtronic Aortic Root Cannula. The recall is due to the potential for excess material in the male luer connectors on the aortic cannula.
The affected kits were distributed in California, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, and West Virginia. The recalled product is identified by UDI/DI 10195327563561 (each) and 40195327563562 (case), with lot numbers 24BMB798, 24DMH381, 24EMF949, 24GMF161, and 24IMB237.
Patients or healthcare facilities that have received this product should discontinue use and contact Medline Industries or their healthcare provider for instructions on return or replacement. The FDA has classified this recall as Class I.
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
- Hazard
- component-defect
- connector-integrity
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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