Device Recall Impulse Angiographic Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific 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
    45903
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0940-2008
  • 사례 시작날짜
    2007-11-20
  • 사례 출판 날짜
    2008-01-31
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-10-23
  • 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
    Intravascular Diagnostic Catheter - Product Code DQO
  • 원인
    Flash may be protruding from the lumen of the catheter shaft. if this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.
  • 조치
    The firm sent an Urgent Medical Device Recall letter dated 11/20/2007, to all affected hospitals. The letter describes the defect with the catheters and Product Table information including UPNs, Catalog Numbers, Lot/Batch Numbers and Product Descriptions. The firm requests that further distribution or use of any remaining product affected by the recall should cease immediately. ****IMPORTANT INFORMATION: If it is a practice of the hospital to remove product from the outer carton and store on shelves in the inner-pouch only. Users are to review the Product Table carefully and consider both the inner and outer packaging product codes when search for affected/recalled product.****

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :  16599-86/H74916599862/H74916599860/0020033690
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including states of AL, CA, FL, GA, KS, KY, LA, MN, NV, OH, OK, PA, SD, TN, TX, and WI.
  • 제품 설명
    Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-86. 6F AR2 (5-pack). Distal curve AR2. 100 cm length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Natick, MA 01760-1537 USA.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Boston Scientific, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA