Device Recall Needle Counters 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health 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
    63951
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0985-2013
  • 사례 시작날짜
    2012-12-18
  • 사례 출판 날짜
    2013-03-28
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-08-01
  • 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
    Tray, surgical, instrument - Product Code FSM
  • 원인
    Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
  • 조치
    Cardinal Health sent an Urgent Product Recall letter dated December 18, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immedaitely stop using affected product and discard any product that may be on hand, return the enclosed acknowledgement form, notify any customers to whom you may have distributed product affected by this recall, and contact the appropriate Customer Service group to arrange for credit of any affected product discarded. For questions contact Cardinal Health Professional Services at 800-292-9332.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 4FA70SSA Lot Numbers: all lot numbers less than or equal to 931750  Catalog Number: 4FM70SSA Lot Numbers: all lot numbers less than or equal to 912173
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
  • 제품 설명
    Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) || Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM70SSA) || Product Usage: || Disposal system for counting of used surgical blades and needles.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • 제조사 모회사 (2017)
  • Source
    USFDA