Events

BioSentry" Tract Sealant System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Surgical Specialties Mexico S DE RL DE CV 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
    75273
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0068-2017
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149916
  • 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
    Absorbable lung biopsy plug - Product Code OMT
  • 원인
    Surgical specialties mexico is recalling the biosentry track sealant system due to the potential for an open seal on the product package.
  • 조치
    An Urgent Product Recall Notification Letter dated 9/24/16 was sent to customers to inform them that Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package. The letter informs the customers to complete the customer acknowledgement form and return via fax to their quality assurance department at (610) 404-4010 or return via email to kknappenberger@surgicalspecialties.com. Customers with questions are instructed to contact Kelly Knappenberger at (484) 220-2402 or Kris Liberacki at (262) 994-8083.

Device

BioSentry" Tract Sealant System
  • 모델명 / 제조번호(시리얼번호)
    MAWX380, MAZD460, MAZR350, MBCF540
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US: OH, PA, CO, MA, DE, CA, NY, VA, WA, NJ, CT, FL, TX, NH, ID, OK, AZ, GA, PA, NV, VT. Worldwide: Spain, Italy, United Kingdom, Portugal, Turkey, Germany, Denmark,
  • 제품 설명
    BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
  • Manufacturer
    Surgical Specialties Mexico S DE RL DE CV

Manufacturer

Surgical Specialties Mexico S DE RL DE CV
  • 제조사 주소
    Surgical Specialties Mexico S DE RL DE CV, Corredor Tijuana - Rosarito 2000-24702 B, Ejido Francisco Villa, Tijuana Mexico
  • 제조사 모회사 (2017)
    Angiotech Pharmaceuticals, Inc.
  • Source
    USFDA