Medtronic Perfusion Systems: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; 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: 481 units Lot/code info: GTIN 00643169454460, Lot Numbers: 0231665646; GTIN 20643169454464, Lot Numbers: 0231665646, 0231665648.

UPC codes

00643169454460, 20643169454464

Source

Official record: FDA (Device enforcement) ↗

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