Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC
FDA device recall Z-1456-2025 · posted 2025-04-04 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula
- 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.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- OEZ
- Quantity affected
- 1310 units
- Distribution
- US: CA, FL, MN, NY, OH, OR, PA, TX, WV
- Date initiated
- 2025-02-21
- Date posted
- 2025-04-04
- Location
- Northfield, IL
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