Medline Medical Procedure Kits with Aortic Root Cannula Recalled
Medline is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to potential excess material in the male lures on the cannula. The recall affects 468 units distributed across nine US states.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device (aortic root cannula used in cardiac procedures). Class I recalls are inherently assigned a severity score of at least 4 per the rubric, regardless of whether illnesses have been reported.
Plain-English summary
Medline Industries, LP is recalling medical procedure kits that contain a Medtronic Aortic Root Cannula. The kits are labeled as "TOL DR R PACK" and are being recalled due to the potential presence of excess material in the male lures on the aortic cannula.
A total of 468 units have been distributed in the United States, specifically in California, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, and West Virginia.
The affected kits are identified by multiple lot numbers across three different UDI/DI codes: - UDI/DI 10195327166304 (ea) / 40195327166305 (case): Lot Numbers 22GBL197, 22JBG283 - UDI/DI 10195327273484 (ea) / 40195327273485 (case): Lot Numbers 23ABO787, 23EBT153, 23HBB950 - UDI/DI 10195327503390 (ea) / 40195327503391 (case): Lot Numbers 24CBL126, 24EBV315, 24EBW136
Customers who have received these kits should stop using them and contact Medline Industries or their supplier for further instructions.
The recalled product
- Product
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 468
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- TOL DR R PACK
- UDI/DI 10195327166304 (ea) 40195327166305 (case)
- Lot Numbers 22GBL197
- 22JBG283
- UDI/DI 10195327273484 (ea) 40195327273485 (case)
- Lot Numbers 23ABO787
- 23EBT153
- 23HBB950
- UDI/DI 10195327503390 (ea) 40195327503391 (case)
- Lot Numbers 24CBL126
- 24EBV315
- 24EBW136.
Distribution
Part of a larger recall action
This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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