Events

Device Recall EMPIRA (TM) RX PTCA Dilatation Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cordis 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
    68834
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2557-2014
  • 사례 시작날짜
    2014-06-23
  • 사례 출판 날짜
    2014-08-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128819
  • 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
    Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
  • 원인
    The balloon may exhibit resistance to the removal of the balloon cover. weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. this may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
  • 조치
    Cordis Corp sent Urgent Medical Device Correction Letters dated June 23, 2014, to all affected customers. Those in the Foreign Countries were sent via E-mail dated June 23, 2014. The letter identified the product the problem and the action needed to be taken by the customer. Cordis and Creganna-Tactx are not removing the products, but rather providing additional labeling (customer letter) advising the user not to use the product if unusual resistance is felt during removal of the balloon cover. Cordis and Creganna-Tactx explained in the letter to the consignees that is is known that balloons with hydrophilic coating are susceptible to expansion of the coating at extremely elevated humidity, therefore, it is important for the User to follow the current labeling, to store the product in a cool, dark and dry place. Action requested on your part: "Pass on this letter to anyone who needs to be informed in your facility and in any facility where potentially affected devices may have been transferred. "Maintain awareness of this communication until the information has been incorporated into the Cordis EMPIRA" NC RX and EMPIRA" RX PTCA dilatation catheter labeling. "Retain this letter with affected product. "Report all balloon cover removal difficulties through the standard complaint process. "For questions related to the issue please contact Cordis Endovascular Medical information Line 877-DEVICE5 (877-338-4235), Monday through Friday from 9:00AM to 5:00 PM EDT. "For questions related to the Acknowledgment Form and its return, please contact Cordis QA at (786) 313-8730.

Device

Device Recall EMPIRA (TM) RX PTCA Dilatation Catheter
  • 모델명 / 제조번호(시리얼번호)
    70 Catalog numbers:  85R06150S, 85R06200S, 85R06225S, 85R06250S, 85R06275S, 85R06300S,  85R06325S, 85R06350S, 85R06375S, 85R06400S, 85R10150S, 85R10200S, 85R10225S,85R10250S, 85R10275S, 85R10300S, 85R10325S, 85R10350S, 85R10375S, 85R10400S, 85R12150S, 85R12200S, 85R12225S, 85R12250S, 85R12275S, 85R12300S, 85R12325S, 85R12350S, 85R12375S, 85R12400S, 85R15150S, 85R15200S, 85R15225S, 85R15250S, 85R15275S, 85R15300S, 85R15325S, 85R15350S, 85R15375S, 85R15400S, 85R20150S, 85R20200S, 85R20225S, 85R20250S, 85R20275S, 85R20300S, 85R20325S, 85R20350S, 85R20375S, 85R20400S, 85R25150S, 85R25200S, 85R25225S, 85R25250S, 85R25275S, 85R25300S, 85R25325S, 85R25350S, 85R25375S, 85R25400S, 85R30150S, 85R30200S, 85R30225S, 85R30250S, 85R30275S, 85R30300S 85R30325S, 85R30350S, 85R30375S, and 85R30400S.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.
  • 제품 설명
    Cordis EMPIRA RX PTCA Dilatation Catheter
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • 제조사 주소
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • 제조사 모회사 (2017)
    Cardinal Health
  • Source
    USFDA