Events

Device Recall Heparin Lock Flush 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Excelsior Medical Corp 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
    61823
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1707-2012
  • 사례 시작날짜
    2012-05-07
  • 사례 출판 날짜
    2012-06-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109178
  • 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
    Heparin, vascular access flush - Product Code NZW
  • 원인
    Some lots of heparin lock flush, usp syringes (3 ml fill in 10 ml syringe, 4 ml fill in 10 ml syringe, 5 ml fill in 10 ml and 6 ml in 10 ml syringe), failed anti-factor iia assay for potency.
  • 조치
    Excelsior Medical sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using the affected product and to complete and return an attached Customer Reply Form via fax to (866) 807-3714. Contact Excelsior Medical Customer Service at (800) 487-4276 for questions regarding this recall. A second letter which included additional lots was sent out on 5/25/2012 with the date of 5/24/2012. A return response form was also included.

Device

Device Recall Heparin Lock Flush
  • 모델명 / 제조번호(시리얼번호)
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6/1/2012 PS100U 90-126-9D 6/1/2012 PS100U 91-139-9D 7/1/2012 PS100U 92-002-9D 8/1/2012 PS100U 93-016-9D 9/1/2012 PS100U 93-018-9D 9/1/2012 PS100U 94-119-9D 10/1/2012 PS100U 94-120-9D 10/1/2012 PS100U 95-129-9D 11/1/2012 PS100U 96-008-9D 12/1/2012 PS100U 96-012-9D 12/1/2012 PS100U 96-018-9D 12/1/2012
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Brazil, Canada, and Colombia.
  • 제품 설명
    Heparin Lock Flush Solution 100 Unit/mL, USP || 3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush Syringe ZR || Excelsior Medical Neptune, NJ 07753 || (800) 487-4276 || Made in USA || NDC 63807060055. || Used to maintain patency of vascular access devices designed for intermittent infusion therapy. Export product for sale in Colombia are used for locking hemodialysis catheters, for heparinization of extracorporeal systems, in hemodialysis, and for peritoneal dialysis.
  • Manufacturer
    Excelsior Medical Corp

Manufacturer

Excelsior Medical Corp
  • 제조사 주소
    Excelsior Medical Corp, 1933 Heck Ave, Neptune NJ 07753
  • 제조사 모회사 (2017)
    Medline Industries Inc.
  • Source
    USFDA