Events

Device Recall Breast Biopsy Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Custom Healthcare Systems, 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
    64084
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0797-2013
  • 사례 시작날짜
    2012-11-26
  • 사례 출판 날짜
    2013-02-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115339
  • 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
    Tray, biopsy, without biopsy instruments - Product Code FCH
  • 원인
    Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
  • 조치
    Custom Healthcare Systems, Inc. sent an Urgent Recall Letter dated November 19, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory, quarantine affected product and return affected product to Stericycle using the label provided with the letter. Customer were also requested to complete and return the enclosed recall response form. For questions contact Hospira Customer Care at 1-877-946-7747.

Device

Device Recall Breast Biopsy Kit
  • 모델명 / 제조번호(시리얼번호)
    LOT NO. 60812 EXPIRES: 11 /2012
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
  • 제품 설명
    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. || Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
  • Manufacturer
    Custom Healthcare Systems, Inc.

Manufacturer

Custom Healthcare Systems, Inc.
  • 제조사 주소
    Custom Healthcare Systems, Inc., 4205 Eubank Rd, Richmond VA 23231-4328
  • 제조사 모회사 (2017)
    Custom Healthcare Systems Inc.
  • Source
    USFDA