Events

Perfusion Tubing Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sorin Group USA, 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
    57052
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0370-2011
  • 사례 시작날짜
    2010-10-07
  • 사례 출판 날짜
    2010-11-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95253
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • 원인
    Defective product packaging may compromise product sterility.
  • 조치
    Sorin Group sent an "URGENT: FIELD SAFETY NOTICE" letter dated October 7, 2010, to all customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to check all affected inventory to exam for holes. Any damaged products were to be returned to Sorin. If no damage was found, product could be used. The customers were also instructed to contact Sorin Cardiopulmonary Customer Service at 1-800-650-2623 to return product and receive replacement; they were to share this information with all personnel who may use this product; and to complete and return the attached Customer Response Form via the self-addressed prepaid envelope provided or fax to (303) 467-6502 as soon as possible. For further information, contact 1-800-650-2623.

Device

Perfusion Tubing Set
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 1008200023, 1010300027, 1011800027, 1016100025
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
  • 제품 설명
    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500200, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • 제조사 주소
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • 제조사 모회사 (2017)
    LivaNova PLC
  • Source
    USFDA