Device Recall Perfadex with THAM

  • Modelo / Serial
    Addex THAM 50, lot number 2570350.  Relabeled and distributed as THAM, REF 99019, lots 502518, 502590, 502663, 502664, 502688, 502709, 502735, 502774, 502809, 502822, 502834.  Perfadex with THAM kit, 8 x 1000mL REF 19017,  502522 (502518) 502591 (502590) 502662 (502664) 502689 (502688) 502734 (502735) 502807 (502809) 502835 (502834). (Number in parenthesis is THAM LOT number used in kit)  Perfadex with THAM kit 2 x 2800mL REF 19018:  502521 (502518) 502663 (502664) 502708 (502709) 502743 (502774) 502808 (502809) 502823 (502822) 502826 (502822). (Number in parenthesis is THAM LOT number used in kit)
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution including USA and Europe.
  • Descripción del producto
    XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs. || Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Vitrolife, Inc., 3601South Inca Street, Englewood CO 80110
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA