Events

STORZ High Flow Insufflation Tubing (with filter) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Karl Storz Endoscopy 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    78289
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0098-2018
  • 사례 시작날짜
    2017-10-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159075
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Tubing/tubing with filter, insufflation, laparoscopic - Product Code NKC
  • 원인
    The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
  • 조치
    The recalling firm issued letters flagged as 'SAFETY ALERT" dated 10/5/2017 via Federal Express on 10/10/2017.

Device

STORZ High Flow Insufflation Tubing (with filter)
  • 모델명 / 제조번호(시리얼번호)
    Lot #129241
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.
  • 제품 설명
    STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR. The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.
  • Manufacturer
    Karl Storz Endoscopy

Manufacturer

Karl Storz Endoscopy
  • 제조사 주소
    Karl Storz Endoscopy, 2151 E Grand Ave, El Segundo CA 90245-5017
  • 제조사 모회사 (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA