Device Recall LEEP

  • 모델명 / 제조번호(시리얼번호)
    Lot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including Puerto Rico
  • 제품 설명
    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

제조사

  • 제조사 주소
    Cooper Surgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
  • 제조사 모회사 (2017)
  • Source
    USFDA