Device Recall Covidien Valley Lab

  • 모델명 / 제조번호(시리얼번호)
    Affected Lot Range: 210654X through 61380120X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • 제품 설명
    Valleylab Laparoscopic Curved Spatula Electrode 36CM || Item Code: E277136 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic, 60 Middletown Ave, North Haven CT 06473-3908
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 16 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Affected Lot Range: 210141X through 61220104X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • 제품 설명
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes || Item Code: E253028 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Affected Lot Range: 210286X through 61220102X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • 제품 설명
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" || Item Code: E25306 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Affected Lot Range: 211742X through 60870082X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • 제품 설명
    Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM || Item Code: E258128 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Affected Lot Range: 216416X through 60080002X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • 제품 설명
    Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM || Item Code: E258228 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Affected Lot Range: 210556X through 60520063X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • 제품 설명
    Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm || Item Code: E258328 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
하나 더 11 건 더