Events

Device Recall 3M Ranger(TM) Pressure Infusor, Model 145 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 3M Company - Health Care Business 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
    77399
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2632-2017
  • 사례 시작날짜
    2017-05-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155950
  • 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
    Infusor, pressure, for i.V. Bags - Product Code KZD
  • 원인
    It was discovered that one ranger pressure lnfusor model 145, sn: 100873, produced a left chamber pressure that was slightly below the manufacturing specification.
  • 조치
    The firm, 3M, sent a letter dated 5/22/2017, to its consignee/customer. The letter described the product, problem and actions to be taken. The consignee was informed that there is no safety issue; however, the firm will be replacing unit. In addition, a representative from 3M will be visiting the facility and exchanging the product for a new one. Please feel free to call (713) 292-4430 or email baprestera@mmm.com if you have any questions.

Device

Device Recall 3M Ranger(TM) Pressure Infusor, Model 145
  • 모델명 / 제조번호(시리얼번호)
    Serial Number: 100873
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    U.S. Distribution: TX only
  • 제품 설명
    3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 || The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • 제조사 주소
    3M Company - Health Care Business, 3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144-0001
  • 제조사 모회사 (2017)
    3m Company
  • Source
    USFDA