Medline medical procedure kits recalled for aortic cannula connector defect
Medline is recalling 1,247 medical procedure kits containing Medtronic Aortic Root Cannula due to excess material in male connectors. The defect poses risks during cardiac procedures and affects kits distributed across nine U.S. states.
What this means for you
Illness, injury, or structural failure has been reported. 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 critical cardiac medical device. Per the severity guidelines, FDA Class I recalls never score below 4. Although no illnesses or injuries have been reported, the potential manufacturing defect in an aortic cannula used during cardiopulmonary bypass procedures justifies the Severe classification.
Plain-English summary
Medline Industries, LP is recalling medical procedure kits containing Medtronic Aortic Root Cannula, used in cardiac procedures. The affected kits are labeled CPB ADJUNCT PACK, DR. C PACK, TOL DR R PACK, TOL DR. C PACK, TOL DR. CRESCENZO PACK, and TOL DR. M PACK, affecting a total of 1,247 units.
The recall is due to potential excess material in the male lures (connectors) on the aortic root cannula. This manufacturing defect on a critical medical device poses a risk during cardiac procedures.
Affected kits were distributed to medical facilities in California, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, and West Virginia. This was designated as a Class I recall by the FDA.
The recalled product
- Product
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- excess-material
- luer-defect
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 (20)
- TOL DR R PACK
- UDI/DI 10198459054242 (ea) 40198459054243 (case)
- Lot Number 24IBV027
- TOL DR. C PACK
- UDI/DI 10195327176914 (ea) 40195327176915 (case)
- Lot Number 22HBX339
- TOL DR. CRESCENZO PACK
- UDI/DI 10195327273750 (ea) 40195327273751 (case)
- Lot Numbers 22LBC389
- 23EBQ439
- 23HBG138
- UDI/DI 10195327513818 (ea) 40195327513819 (case)
- Lot Numbers 23KBS878
- 24CBB191
- 24EBD828
- UDI/DI 10198459054259 (ea) 40198459054250 (case)
- Lot Numbers 24FBO426
- 24HBP282
- 24JBL545
- 24LBR173
Distribution
Distributed in 9 states:
- CA
- FL
- MN
- NY
- OH
- OR
- PA
- TX
- WV
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