Device Recall LEEP

  • Modèle / numéro de série
    Lot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including Puerto Rico
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Cooper Surgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
  • Société-mère du fabricant (2017)
  • Source
    USFDA