Device Recall Hospira LatexFree Blood Secondary Set, 26 Inch 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hospira 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
    58276
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2024-2011
  • 사례 시작날짜
    2011-03-28
  • 사례 출판 날짜
    2011-04-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-05-09
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
    Instrument, surgical, disposable - Product Code KDC
  • 원인
    There is a potential for the air filter at the distal end of the set to become detached. this could result in the contamination of the sterile fluid path inside the tubing.
  • 조치
    The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated March 28, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return the Reply Form via fax to 1-866-324-3734, even if you do not have the affected product; inform healthcare professionals in their organization of this recall; if they have distributed the product further, notify their accounts and have them fax the reply form to 1-866-324-3724; return the affected product to Stericycle using labels provided, and call Stericycle at 1-877-877-0481, if they have not received a return label. For medical inquiries, please call Hospira Medical Communications at 1-800-615-0187. Call Hospira Global Product Safety and Complaints at 1-800-441-4100 (8am-5pm CST, M-F) or by e-mail at (ProductComplaintsPP@hospira.com).

Device

  • 모델명 / 제조번호(시리얼번호)
    List No. 4602-58, lot 940405H
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Canada, Korea and Singapore.
  • 제품 설명
    Hospira Latex-Free Blood Secondary Set, 26 Inch with Secure Lock; a sterile Rx tubing set for the administration of fluids from a blood bag in series with an I.V. solution bottle and I.V. set; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA; List No. 4602-58 || For the administration of fluids from a blood bag in series with an I.V. solution bottle and I.V. set
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • 제조사 모회사 (2017)
  • Source
    USFDA