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Class IOngoingZ-1457-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Apr 16, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK

Lot / code information

Lot #
22GBL197, 22JBG283; TOL DR R PACK, UDI/DI 10195327273484 (ea) 40195327273485 (case)
Lot #
23ABO787, 23EBT153, 23HBB950; TOL DR R PACK, UDI/DI 10195327503390 (ea) 40195327503391 (case)
Lot #
24CBL126, 24EBV315, 24EBW136

What the firm 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 recalls@medline.com.

DistributionShow details

US: CA, FL, MN, NY, OH, OR, PA, TX, WV

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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