Recall Z-1458-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated February 21, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
Codes / lots: HEART BASIN PACK-LF, UDI/DI 10195327563561 (ea) 40195327563562 (case), Lot Numbers 24BMB798, 24DMH381, 24EMF949, 24GMF161, 24IMB237.
Reason for recall
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.
FDA-determined cause: Other
Action taken
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 recalls@medline.com.
Details
- Recall number
- Z-1458-2025
- Initiated
- February 21, 2025
- Posted by FDA
- April 4, 2025
- Product code
- KDD – Kit, Surgical Instrument, Disposable
- Quantity
- 320 units
- Distribution
- US: CA, FL, MN, NY, OH, OR, PA, TX, WV
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1456-2025 Class I | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as…Medline medical procedure kits, containing Medtronic Aortic Root Cannula | 02/21/2025Open, Classified |
| Z-1457-2025 Class I | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as…Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential… | 02/21/2025Open, Classified |
| Z-1459-2025 Class I | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as…Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential… | 02/21/2025Open, Classified |