Cook Incorporated: Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include

Hazard

Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.

Details from the source

Reason for recall: Cook Medical identified that catheters supplied in the affected device lots may experience tip separation. Distribution: Worldwide distribution. Quantity: 26986 units Lot/code info: 1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260202(10)15881668 (product), (01)10827002087962(17)260202(30)5(10)15881668 (box), Lot Number 15881668; 1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260219(10)15903001 (product), (01)10827002087962(17)260219(30)5(10)15903001 (box), Lot Number 15903001; 1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260306(10)NS15932463 (product), (01)10827002087962(17)260306(30)5(10)NS15932463 (box), Lot Number NS15932463; 2) HNBR5.0-35-100-P-NS-DAV (RPN) G08699 (GPN), UDI: (01)00827002086999(17)260411(10)16003554 (product), (01)10827002086996(17)260411(30)5(10)16003554 (box), Lot Number 16003554; 3) HNBR5.0-35-100-P-NS-H1 (RPN) G08421 (GPN), UDI: (01)00827002084216(17)260314(10)15948423 (product), (01)10827002084213(17)260314(30)5(10)15948423 (box), Lot Number 15948423; 4) HNBR5.0-35-100-P-NS-JB2 (RPN) G08809 (GPN), UDI: (01)00827002088092(17)260319(10)15953578 (product), (01)10827002088099(17)260319(30)5(10)15953578 (box), Lot Number 15953578; 5) HNBR5.0-35-100-P-NS-SIM1 (RPN) G08471 (GPN), UDI: (01)00827002084711(17)260401(10)15984088 (product), (01)10827002084718(17)260401(30)5(10)15984088 (box), Lot Number 15984088; 6) HNBR5.0-35-100-P-NS-SIM2 (RPN) G08422 (GPN), UDI: (01)00827002084223(17)260220(10)15907359 (product), (01)10827002084220(17)260220(30)5(10)15907359 (box), Lot Number 15907359; 7) HNBR5.0-35-100-P-NS-SIM3 (RPN) G08597 (GPN), UDI: (01)00827002085978(

UPC codes

00827002087965, 10827002087962, 00827002086999, 10827002086996, 00827002084216, 10827002084213, 00827002088092, 10827002088099, 00827002084711, 10827002084718, 00827002084223, 10827002084220, 00827002085978, 10827002085975, 00827002114838, 10827002114835, 00827002128996, 10827002128993, 00827002357334, 10827002357331, 00827002357365, 10827002357362, 00827002357372, 10827002357379, 00827002097513, 10827002097510, 00827002314085, 10827002314082, 00827002084414, 10827002084411, 00827002084421, 10827002084428, 00827002084438, 10827002084435, 00827002114586, 10827002114583, 00827002570153, 10827002570150, 00827002084698, 10827002084695

Source

Official record: FDA (Device enforcement) ↗

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