Device Recall Sarns Flexible Weighted Sucker 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems Corporation 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
    58125
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2005-2011
  • 사례 시작날짜
    2011-02-25
  • 사례 출판 날짜
    2011-04-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-12-10
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • 원인
    The firm has received two reports of the terumo weighted flexible sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. the firm has determined that the products's instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. however this is not stated in the ifu. the firm is conducting.
  • 조치
    SEE UPDATE BELOW IN ALL CAPS. The firm, Terumo Cardiovascular Systems (Terumo CVS), sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that the product's Indications For Use (IFU) are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However, this is not stated in the IFU. In addition, the customers were instructed to read and understand the changes and clarifications to the product's IFU; review the Medical Device Correction notice; assure that all users are aware of this notice, and confirm receipt of this communication by faxing the attached Customer Response Form via fax to: Terumo CVS Customer Service at 800-292-6551 (US only). If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818. Customers Service hours: Monday-Friday, 8AM-6PM. ON 8/30/2011 THE FIRM ISSUE A LETTER ENTITLED "URGENT MEDICAL DEVICE RECALL" THAT STATED "AFTER FURTHER CONSIDERATION, TERUMO CVS DECIDED TO DISCONTINUE SALES OF THE WEIGHTED FLEXIBLE SUCKER AND IS ASKING USERS TO RETURN ALL UNUSED PRODUCT" TO THE FIRM.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: KG30, KK11, KN17, LA12, LC02, LD23, LF04, LG15, LG29, LK03, LL28, and MG01.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.
  • 제품 설명
    Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-03, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
  • Source
    USFDA