Events

Device Recall North Coast MediTek Inc Biopsy Trays 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 North Coast Medi-Tek 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
    59386
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2982-2011
  • 사례 시작날짜
    2011-05-13
  • 사례 출판 날짜
    2011-08-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102584
  • 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
    General surgery tray - Product Code LOR
  • 원인
    During routine bioburden testing, unusually high results were found for a bioburden test done on 4/19/11. bioburden level reported as >150,000 cfu. our alert level is 17,000 cfu and the action level is 23,000 cfu.
  • 조치
    North Coast Medi - Tek Inc. sent a URGENT PRODUCT RECALL letter dated May 13, 2011 to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customers were instructed to stop shipment of all remaining product and return to recalling firm. They were also requested to contact their customers and notify them of the recall and retieve all remaining product. For further questions please call (440) 974-0750.

Device

Device Recall North Coast MediTek Inc Biopsy Trays
  • 모델명 / 제조번호(시리얼번호)
    Model #'s: 255566, 260945, XP-2033, 266970, XP-1800R1, 254112 & NC-4072, Lot #1114 Exp. 10/13
  • 유통
    Nationwide Distribution CA, CO, FL, GA, ID, IL, MA, NC, NE, NY, OH, OK, PA, TN, NC and TX
  • 제품 설명
    Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. || Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies
  • Manufacturer
    North Coast Medi-Tek Inc

Manufacturer

North Coast Medi-Tek Inc
  • 제조사 주소
    North Coast Medi-Tek Inc, 8603 East Ave, Mentor OH 44060-4366
  • Source
    USFDA