CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.

Reason: The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.

Code information: Part No. 70104.8012 and 70104.8012R; UDI-DI: 04037691658384; Serial no. 90410021, 90410029, 90410165, 90410254, 90410255, 90410024, 90410025, 90410026, 90410028, 90410030, 90410031, 90410034, 90410035, 90410036, 90410043, 90410044, 90410045, 90410046, 90410047, 90410048, 90410049, 90410050, 90410051, 90410052, 90410053, 90410054, 90410055, 90410056, 90410057, 90410058, 90410059, 90410060, 90410061, 90410062, 90410063, 90410064, 90410065, 90410067, 90410068, 90410069, 90410070, 90410071, 90410072, 90410073, 90410074, 90410075, 90410076, 90410077, 90410078, 90410079, 90410080, 90410081, 90410082, 90410084, 90410085, 90410086, 90410087, 90410088, 90410089, 90410091, 90410093, 90410094, 90410095, 90410096, 90410097, 90410098, 90410099, 90410100, 90410101, 90410102, 90410103, 90410104, 90410105, 90410106, 90410107, 90410108, 90410109, 90410110, 90410111, 90410112, 90410113, 90410114, 90410115, 90410116, 90410117, 90410118, 90410119, 90410120, 90410121, 90410122, 90410123, 90410124, 90410125, 90410126, 90410127, 90410130, 90410131, 90410132, 90410133, 90410134, 90410135, 90410136, 90410137, 90410138, 90410139, 90410140, 90410141, 90410142, 90410143, 90410144, 90410146, 90410147, 90410148, 90410149, 90410151, 90410152, 90410153, 90410154, 90410155, 90410156, 90410157, 90410158, 90410159, 90410160, 90410161, 90410162, 90410163, 90410166, 90410167, 90410168, 90410169, 90410170, 90410172, 90410173, 90410174, 90410175, 90410176, 90410177, 90410178, 90410179, 90410180, 90410181, 90410182, 90410183, 90410184, 90410185, 90410186, 90410187.

Distribution pattern: US Nationwide distribution in the states of NJ & TX.