Device Recall LEEP

  • Modelo / Serial
    Lot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including Puerto Rico
  • Descripción del producto
    LEEP REDIKIT Product No. 6060 || In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Cooper Surgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA