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FDA (Device enforcement)Recalled 2026-04-21class ii

Medtronic Perfusion Systems: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter

Hazard

Certain lots of product have the potential for a sterile barrier breach.

Details from the source

Reason for recall: Certain lots of product have the potential for a sterile barrier breach. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, Unit Quantity: 260 units Lot/code info: GTIN 20643169454815, Lot Numbers: 0231665658, C231786900.

UPC codes

20643169454815

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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