BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Company 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
    75252
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0745-2017
  • 사례 시작날짜
    2016-08-08
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • 원인
    Bd has received multiple reports of units associated with the 23 g x .75 in. bd vacutainer¿ push button blood collection set with 12 in. tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.
  • 조치
    The firm, BD, sent a "URGENT PRODUCT RECALL" letter dated 8/8/2016 to its customer with a return response form via UPS 2nd Day mail on 8/8/2016.The letter described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory for the specific lot numbers, quarantine the product and discontinue the shipment of the affected product; complete and return the Recall Response Form by fax to BD at 1-866-913-0661 or email to bd6835@stericycle.com (even if you do not have any product); return all affected products with completed response form per packing instructions; if you have distributed this product, identify your customers and notify them immediately of this product recall; if you would like BD to conduct the notification to your customers, email your customer list within 3 business days to Matthew.Kelleher@bd.com. if you have any questions or require assistance with the return of the recalled product and/or availability of credit product, contact 1-888-628-0732 between 8Am and 5 PM ET Monday through Friday.

Device

  • 모델명 / 제조번호(시리얼번호)
    5355531 5355533 5356681 5356682 6006629 6006630 6006631 6006633 6006634 6006650
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution- US (nationwide) and countries of: Canada, Belgium, Brazil.
  • 제품 설명
    BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood || Collection Set with 12 in. Tubing || Catalog # 367342 || Intended for venipuncture to obtain blood specimens from patients.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • 제조사 모회사 (2017)
  • Source
    USFDA