Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PA

FDA device recall Z-1459-2025 · posted 2025-04-04 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

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.

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

LRO

Quantity affected

1247 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