Events

Device Recall Temno 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carefusion 2200 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
    56085
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2111-2010
  • 사례 시작날짜
    2010-06-25
  • 사례 출판 날짜
    2010-07-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-01-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92609
  • 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
    Guide, needle, surgical - Product Code GDF
  • 원인
    The introducer needle is only 10 cm in length instead of the required 15 cm.
  • 조치
    Cardinal Health, on behalf of CareFusion, telephoned the customers on June 15, 2010 and sent a follow-up "URGENT: PRODUCT RECALL" letter on the same date via UPS next day air. The letter describes product, problem, and action taken by customers. The customers were instructed to immediately stop using affected product, return the enclosed acknowledgment form via fax to 847-686-9101 (note: Cardinal Health is required to confirm receipt of this notification from the customers), notify any customers to whom they may have distributed product to, contact CareFusion Customer Service at 800-653-6827 to arrange for credit and return of the affected product, and send the affected product to CareFusion, 1240 Waukegan Rd, Waukegan, IL 60085, Attn: Scott Fitzer, after obtaining an RMA/RGA number from CareFusion. If you have any questions, please contact 800-292-9332.

Device

Device Recall Temno
  • 모델명 / 제조번호(시리얼번호)
    Catalog number CCH2220, Lot D09121745
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: California, Florida, Georgia, Illinois, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania.
  • 제품 설명
    Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm); sterile, for single use only sets, 5 sets per case; CareFusion, McGaw Park, IL 60085 USA, Made in Dominican Republic; REF CCH2220 || For use in soft tissue aspiration such as breast, kidney, liver, lung, thyroid, lymph nodes and other various soft tissue masses. It is not intended for use in the bone.
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • 제조사 주소
    Carefusion 2200 Inc, 1500 S Waukegan Rd, Mpwm Bldg., Waukegan IL 60085-6728
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA