Ready To Use ThymoCide 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Wexford Labs 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
    66391
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0358-2014
  • 사례 시작날짜
    2013-09-10
  • 사례 출판 날짜
    2013-11-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-04-23
  • 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
    Disinfectant, medical devices - Product Code LRJ
  • 원인
    Expired active ingredient was used in the manufacture of the product.
  • 조치
    Wexford Labs, Inc. sent undated letters by e-mail to affected customers beginning September 10, 2013, and follow-up phone calls were initiated requesting return of the affected product. E-mail letters dated September 26, 2013, were issued requesting return of product and asking the customers to notify their downstream customers. Customers with questions were instructed to call 800-506-1146. For questions regarding this recall call 314-966-4134,

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 091721, exp. 10/13; 101521, exp. 11/13; 0109131, exp. 2/14; 0215131, exp. 3/14; 0320131, exp. 4/14; 0415132, exp. 5/14; 0516131, exp. 6/14; and 0624131, 7/14.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution - USA including FL, SC, TX, MO, CA, OH, OK, MA, IN, and GA.
  • 제품 설명
    Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. || For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Wexford Labs Inc, 325 Leffingwell Ave, Kirkwood MO 63122-6409
  • 제조사 모회사 (2017)
  • Source
    USFDA