Skip to content

Medline medical procedure kits, containing Medtronic Aortic… recallZ-1456-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Feb 21, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Medline medical procedure kits, containing Medtronic Aortic Root Cannula

FDA root cause category: Other

What the company is doing

Medline issued a MEDTRONIC MEDICAL DEVICE RECALL NOTICE to its consignees on 02/21/2025 via email. The notice explained the issue and potential risk. Upon receipt of the completed recall response form, over-labels will be provided, which are to be placed on kits that contain the recalled component and will state the affected component shall be removed and discarded from further use. Distributors, or those who have resold or transferred this product to another company or individual were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-1456-2025
Status
Open, Classified
Initiated by the company
Feb 21, 2025
Posted by the FDA
Apr 4, 2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1310 units
Product code
OEZ
Distribution
US: CA, FL, MN, NY, OH, OR, PA, TX, WV

Product description

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG 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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

CABG OPNHRT S HSP, UDI/DI 10195327449650 (EA) 40195327449651 (case), Lot Numbers 23IBH906, 24EBC446, 24FMC989, 24GME639; CABG OPNHRT S HSP, UDI/DI 10198459089503 (EA) 40198459089504 (case), Lot Numbers 24KMB217, 25AMG162; CARDIAC CABG, UDI/DI 10195327490362 (EA) 40195327490363 (case), Lot Numbers 23LBV500, 24DBS178, 24EBK724, 24FBL825; CARDIAC PACK, UDI/DI 10195327490355 (EA) 40195327490356 (case), Lot Numbers 24CBN830, 24DBS177; DR D AC PACK, UDI/DI 10195327298258 (EA) 40195327298259 (case), Lot Numbers 23HBD834, 23IBF066; HEART BASIN PACK-LF, UDI/DI 10195327047573 (EA) 40195327047574 (case), Lot Numbers 22GMD767, 22JMD290, 23GMC713, 23IMA561, 23KMC902; K OH COMPONENT PACK, UDI/DI 10195327659684 (EA) 40195327659685 (case), Lot Numbers 24EBT996, 24IBR766, 24KBJ595, 24LBQ493; OPEN HEART ADULT PART 1 CDS, UDI/DI 10195327034726 (EA) 40195327034727 (case), Lot Number 24CBG813; OPEN 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; OPEN HEART PACK, UDI/DI 10889942934164 (EA) 40889942934165 (case), Lot Number 23JBD049; Z OPEN HEART, UDI/DI 10195327659882 (EA) 40195327659883 (case), Lot Numbers 24EBT606, 24IBE093, 24JBV568, 24KBR945.

Devices named in this recall

11 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96443).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page