Adelante Breezway 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Oscor, 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
    75785
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0797-2017
  • 사례 시작날짜
    2016-10-05
  • 사례 상황
    Open, Classified
  • 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
    Introducer, catheter - Product Code DYB
  • 원인
    Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
  • 조치
    Oscor sent two(2) Product Recall notifications: -HOSPITALS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Review, complete, sign and return the enclosed Acknowledgement Form attached in the letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable). Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2511 or email RGA@Oscor.com Hours of operations: Monday to Friday from 8:30AM to 5:30PM Eastern Time. - DISTRIBUTORS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Please pull a list of the hospitals (end user) impacted by the affected lots and retrieve inventory for replacement, if available. Review, complete, sign and return the enclosed Acknowledgement Form (Exhibit A) attached in this letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable). Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2511 or email RGA@Oscor.com Hours of operation: Monday to Friday from 8:30AM to 5:30PM Eastern Standard Time.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot #'s: C1-09372 Exp. November 5, 2017, C1-10142 Exp. April 22, 2018 and OR-04728 Exp. October 21, 2018
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM
  • 제품 설명
    OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM || D84CM Catalog # AB081047 || Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Oscor, Inc., 3816 Desoto Blvd, Palm Harbor FL 34683-1618
  • 제조사 모회사 (2017)
  • Source
    USFDA