Medtronic Perfusion Systems: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; 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: 2620 units Lot/code info: GTIN 00643169454736, Lot Numbers: 0231650787, 0231758255, 0231862812, C231966207; GTIN 00673978188713, Lot Numbers: 0231937422; GTIN 20643169454730, Lot Numbers: 0231650787, 0231650793, 0231758250, 0231758255, 0231758279, 0231758282, 0231823523, 0231862812, 0231937422, C231965721, C231966207, C232428221, C232430086.

UPC codes

00643169454736, 00673978188713, 20643169454730

Source

Official record: FDA (Device enforcement) ↗

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