Device Recall ECOLAB MICROTEK Rolled Probe Cover 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ECOLAB INC 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
    80160
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2332-2018
  • 사례 시작날짜
    2017-11-22
  • 사례 상황
    Completed
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • 원인
    The incorrect ifu was shipped with the product.
  • 조치
    The recalling firm issued letters dated November 21, 2017, informing the customer the incorrect IFU was shipped with the product and a correct version of the IFU is being provided with the letter. The consignee was requested to notify downstream customers to the user level and that a copy of the letter could be forwarded to enhance communication. A Recall Response Form was enclosed for completion to be returned via FAX or email as soon as possible. The letter also informs the consignee that the recalling firm will send additional replacement IFU's if they have product in inventory. For further questions, please call (651) 250-4385.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers D151871, D151961, D161861, D162001, and D162911
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
  • 제품 설명
    ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. || To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).
  • Manufacturer

Manufacturer

  • 제조사 주소
    ECOLAB INC, 1 Ecolab Pl, Saint Paul MN 55102-2739
  • 제조사 모회사 (2017)
  • Source
    USFDA