Medtronic Perfusion Systems: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; 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: 6572 units Lot/code info: GTIN 00643169454521, Lot Numbers: 0231545565, C231958117; GTIN 20643169454525, Lot Numbers: 0231545557, 0231545560, 0231545565, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716, 0231667178, 0231823613, 0231823689, 0231823700, 0231846134, 0231862819, 0231912810, C231958117, C231958118, C231958119, C231958120, C232287623.

UPC codes

00643169454521, 20643169454525

Source

Official record: FDA (Device enforcement) ↗

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