LeMaitre Vascular, Inc.: Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

Hazard

The guide tip can become damaged and result in the tip detaching.

Details from the source

Reason for recall: The guide tip can become damaged and result in the tip detaching. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain. Quantity: 5,604 units Lot/code info: Item No. A4545, A4548, A4554, A4558, A4568; GTIN: 840663109807, 840663109838, 840663109814, 840663109821, 840663109845; Lot No: SST1004, SST1005, SST1006, SST1007, SST1009, SST1010, SST1013, SST1018, SST1019, SST1020, SST1021, SST1022, SST1023, SST1024, SST1025, SST1026, SST1027, SST1028, SST1029, SST1030, SST1031, SST1032, SST1033, SST1034, SST1035, SST1036, SST1037, SST1038, SST1041, SST1042, SST1043, SST1044, SST1045, SST1046, SST1047, SST1048, SST1049, SST1050, SST1051, SST1054, SST1055, SST1056, SST1057, SST1058, SST1059, SST1060, SST1061, SST1062, SST1063, SST1064, SST1065, SST1066, SST1067, SST1068, SST1071.

UPC codes

840663109807, 840663109838, 840663109814, 840663109821, 840663109845

Source

Official record: FDA (Device enforcement) ↗

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