Events

Device Recall Endopledge Sinus Catheter Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Edwards Lifesciences, LLC 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
    59135
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2776-2011
  • 사례 시작날짜
    2011-06-15
  • 사례 출판 날짜
    2011-07-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101311
  • 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
    Possibility of separation of the introducer sheath from the hub on coronary sinus catheters.
  • 조치
    Edwards Lifesciences, LLC sent an Urgent Product Recall - Action Required letter dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusotmers were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards at: Edwards Lifesciences 12060 Lone Peak Pkwy Draper, UT 84020 Attention: Suzanne Carpenter, RGA # Customers were instructed to contact Customer Service to obtain a Returned Goods Authorization number and replacement product . Once customers verified their inventory, they were to complete the attached form and fax it to Edwards at (949) 250-3489. For any questions customers were instructed to call Edwards Customer Service at (800) 424-3278.

Device

Device Recall Endopledge Sinus Catheter Kit
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 751029B, 751036B, 751041B, 755814AB, 763115B, 763119B, 763123B, 763125B, 763127B, 763128B, 763129B, 774333B, 774334B, 774336B, 774337, 774337B, 784527B, 794302B, 794303, 794586, 798587, 818578, 818581, 821595, 831328, 833441, 841434, 848624, 848628, 848632, 856438, 856502, 856509, 856510, 856513.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA. || Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the catheter contamination guard, is packaged with these catheters.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC