Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Medline

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall Medlinesee related information
Date Initiated by FirmFebruary 21, 2025
Date PostedApril 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1456-2025
Recall Event ID 96443
Product Classification Cardiovascular procedure kit - Product Code OEZ
ProductMedline 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 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.
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall		Medline medical procedure kits, containing Medtronic Aortic Root Cannula
FDA Determined
Cause 2		Other
ActionMedline 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 recalls@medline.com.
Quantity in Commerce1310 units
DistributionUS: CA, FL, MN, NY, OH, OR, PA, TX, WV
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-