Events

Device Recall dynarex Specimen Containers 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Dynarex Corporation 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
    73584
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2057-2016
  • 사례 시작날짜
    2016-03-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144534
  • 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
    Container, specimen, non-sterile - Product Code NNI
  • 원인
    Exterior carton is mis-labeled as sterile. non-sterile, bulk specimen containers were packed in incorrect exterior carton.
  • 조치
    On March 2, 2016, dynarex Corporate Headquarters distributed Voluntary Device Recall notices and Recall Verification Forms to their customers via email. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to examine their stock immediately to determine if they have any of the lots listed on hand. If so, discontinue distributing and quarantine the product immediately. Promptly contact the Dynarex Credit & Return representative Avi Celnick (845-365-8200 Ext 6644) to arrange for product return. Customers account will be credited for all returned products. All customers are advised to complete the Voluntary Recall Verification Form and returm immediately via fax or e-mail to Vijay Sachdev (Fax 845-365-8238; v.sachdev@dynarex.com).

Device

Device Recall dynarex Specimen Containers
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 31899, 32014, 32015, 32410 & 32411
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada
  • 제품 설명
    dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only || Product Usage:containers for sample collection
  • Manufacturer
    Dynarex Corporation

Manufacturer

Dynarex Corporation
  • 제조사 주소
    Dynarex Corporation, 10 Glenshaw St, Orangeburg NY 10962-1207
  • 제조사 모회사 (2017)
    Dynarex Corporation
  • Source
    USFDA