Device Recall Infusion Administration Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zevex International, 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
    57829
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1444-2011
  • 사례 시작날짜
    2011-01-24
  • 사례 출판 날짜
    2011-02-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-09-27
  • 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
    Pump, infusion - Product Code FRN
  • 원인
    Defect in tubing may trigger false air-in-line warning.
  • 조치
    The firm, MOOG, sent an "Expansion of Moog/Curlin Ambulatory Pump Administration Set Recall" letter dated May 2, 2011 to its customers. This letter informed the customers that this recall has been expanded to included specific lot numbers of Curlin model ambulatory infusion administration sets. The customers were instructed to follow the outlined process in the letter: remove suspect product code from inventory, contact MOOG Customer Service at 1-800-970-2337, prompt #7, contact your distributor to arrange replacement product, request a shipping return label as per the distributor's process and ship back to their location and follow the temporary solution outlined in the letter. Moog Customer Service will provide a call tag for convenient product return. If you have any questions contact MOOG Customer Service at 1-800-970-2337. The firm, MOOG, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 24, 2011 to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to remove suspect product code from inventory; contact their distributor to arrange replacement product, if purchased from distributor and request shipping return label per distributors process and ship back to their location or contact MOOG Customer Service at 800-970-2337, prompt #7, if purchased directly from MOOG and MOOG Customer Service will provide a call tag for convenient product return; follow the temporary solution provided until replacements are administered; and complete and return the MEDICAL DEVICE CORRECTION REPLY FORM in the self addressed envelope provided. If you have any questions, contact MOOG Customer Service at 800-970-2337.

Device

  • 모델명 / 제조번호(시리얼번호)
    ***EXPANDED*** Additional Lots Added 05/12/2011: CF1018003, CF1019017, CF1022207, CF1029503, CF1029504, CRF10138002.  Lot Codes: CF1018201, CF1018802, CF1018805, CF1019015, CF1019016, CF1020802, CF1022208, CF1022801, CRF10130001, CRF10132001, CRF10134001, CRF10135001, CRF10137001, CRF10145001, CRF10155003, CRF10156001, CRF10158002, CRF10159001, CRF10160001, D100317, D100318.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA including states of: AR, CA, FL, IA, KS, MS, NE, NY, OH, OK, TN, TX, and UT; and countries including: Australia, Croatia, France, Germany, Kuwait, New Zealand, Qatar, Saudi Arabia, South Africa, United Arab Emirates, and UK.
  • 제품 설명
    Curlin Infusion Administration Set, REF 340-4128, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123. || The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Zevex International, Inc., 4314 Zevex Park Ln, Salt Lake City UT 84123
  • 제조사 모회사 (2017)
  • Source
    USFDA