Events

Device Recall RENASYS GO Negative Pressure Wound Therapy 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew, 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
    75966
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1041-2017
  • 사례 시작날짜
    2016-11-11
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151850
  • 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
    negative pressure wound therapy Powered suction pump - Product Code OMP
  • 원인
    Lack of 510k clearance for design modification.
  • 조치
    On letter sent to all their consignees, Smith & Nephew asked to the consignees to removed all existing Renasys Go NPWT Pumps and returned following the instructions on the letter and also removed the affected power supply units identified on the recall letter. Each consignee needs to complete the Acknowledge

Device

Device Recall RENASYS GO Negative Pressure Wound Therapy
  • 모델명 / 제조번호(시리얼번호)
    Model No. 66800164; All pumps of this model are affected.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. || Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • 제조사 주소
    Smith & Nephew, Inc., 970 Lake Carillon Dr Ste 110, Saint Petersburg FL 33716-1130
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA