Device Recall Enteral feeding replacement device. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 C R Bard Inc 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
    50696
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1111-2009
  • 사례 시작날짜
    2008-12-22
  • 사례 출판 날짜
    2009-04-08
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-05-18
  • 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, gastrointestinal (and accessories) - Product Code KNT
  • 원인
    Out of specification replacement gastrostomy device was distributed.
  • 조치
    Consignees were notified by "Product Recall" letter distributed on January 7, 2009 via Federal Express overnight mail and asked to check all inventory locations, remove unused affected product and return to Bard Access Systems, Inc (BAS). Customers were also instructed to complete the enclosed Reply Form and Inventory Reconciliation Form and fax it to BAS at 1-801-522-5674. Additional information is available by calling BAS Customer Service at 1-800-290-1689.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: HUSB1657, HUSB1658, HUSC0106, HUSC0107, HUSD0341, HUSD1912, HUSD2004, HUSD2183, HUSE1567, HUSF1286, HUSG1112, HUSH1636, HUSH1662 and HUSI2708.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution, USA (states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, NH, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV) and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, United Kingdom, Italy, France, Switzerland, Spain and Germany, Australia, and Latin America.
  • 제품 설명
    Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00218W, 24F x 3.4cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. || A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
  • Manufacturer

Manufacturer