Reported Apr 16, 2025 · Ongoing
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP,…
MEDLINE INDUSTRIES, LP - Northfield
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula
- labeled as followsCABG 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
- Lot codes and dates
11 of 11 products
Products covered by this recall # Barcodes Product as published 1 1019532744965040195327449651CABG OPNHRT S HSP, UDI/DI 10195327449650 (EA) 40195327449651 (case), Lot Numbers 23IBH906, 24EBC446, 24FMC989, 24GME639 2 1019845908950340198459089504CABG OPNHRT S HSP, UDI/DI 10198459089503 (EA) 40198459089504 (case), Lot Numbers 24KMB217, 25AMG162 3 1019532749036240195327490363CARDIAC CABG, UDI/DI 10195327490362 (EA) 40195327490363 (case), Lot Numbers 23LBV500, 24DBS178, 24EBK724, 24FBL825 4 1019532749035540195327490356CARDIAC PACK, UDI/DI 10195327490355 (EA) 40195327490356 (case), Lot Numbers 24CBN830, 24DBS177 5 1019532729825840195327298259DR D AC PACK, UDI/DI 10195327298258 (EA) 40195327298259 (case), Lot Numbers 23HBD834, 23IBF066 6 1019532704757340195327047574HEART BASIN PACK-LF, UDI/DI 10195327047573 (EA) 40195327047574 (case), Lot Numbers 22GMD767, 22JMD290, 23GMC713, 23IMA561, 23KMC902 7 1019532765968440195327659685K OH COMPONENT PACK, UDI/DI 10195327659684 (EA) 40195327659685 (case), Lot Numbers 24EBT996, 24IBR766, 24KBJ595, 24LBQ493 8 1019532703472640195327034727OPEN HEART ADULT PART 1 CDS, UDI/DI 10195327034726 (EA) 40195327034727 (case), Lot Number 24CBG813 9 1019532720638340195327206384OPEN HEART B PACK-LF, UDI/DI 10195327206383 (EA) 40195327206384 (case), Lot Numbers 22IMH938, 22KMC295, 23AMD800, 23DME198, 23GMD603, 23GMI093, 23HMG457, 23IMG457, 23KMJ484, 24AMG704, 24AMI684, 24BMG042, 24GMA506, 24GMA897 10 1088994293416440889942934165OPEN HEART PACK, UDI/DI 10889942934164 (EA) 40889942934165 (case), Lot Number 23JBD049 11 1019532765988240195327659883Z OPEN HEART, UDI/DI 10195327659882 (EA) 40195327659883 (case), Lot Numbers 24EBT606, 24IBE093, 24JBV568, 24KBR945. - Amount recalled
- 1310 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
Why it was recalled
Stop using this product now
Medline medical procedure kits, containing Medtronic Aortic Root Cannula
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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