Events

Device Recall Odyssey 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 KooJoo Trading Company 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
    65664
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1729-2013
  • 사례 시작날짜
    2013-07-03
  • 사례 출판 날짜
    2013-07-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-03-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119830
  • 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
    Lancet, blood - Product Code FMK
  • 원인
    Lancets were not sterilized within the dose range established by sterilization validation.
  • 조치
    The firm, KooJoo, sent a "MEDICAL DEVICE VOLUNTARY T RECALL" letter dated July 3, 2013 via first class mail to its customer. The letter described the product, problem and actions to be taken. The customer was instructed to identify and hold all safety lancets you have in inventory that was received before June 2013; notify your retail customers of this product recall and complete and return the attached Customer Reply Form via email to heegonkim@hotmail.com and also return form along with any unused/undistributed product for replacement. If you have further questions, please email heegonkim@hotmail.com or call 209-403-9191 during 9:00am to 5:00pm M-F PST.

Device

Device Recall Odyssey
  • 모델명 / 제조번호(시리얼번호)
    Lot # HBM1303-4886, Exp 3/6/2016; Lot# HBM1303-4886, Exp 3.6 to 3/21/2016; Lot# HBM1201-02, Exp 1/16/2015; Lot# HBM1203-02, Exp 4/5/2015
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution GA only.
  • 제품 설명
    Safety Lancets - Odyssey, Button Activated; || Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. || 26G - Single Use Only, || Made In Korea || Distributed by Hummingbird Medical, Savannah, GA || 100 count Boxes; 40 boxes per case || Blood collection by penetrating skin with needle.
  • Manufacturer
    KooJoo Trading Company

Manufacturer

KooJoo Trading Company
  • 제조사 주소
    KooJoo Trading Company, 116-7 Songma-li, Daegoj-myun, Gimpo City, Gyeongki-Do Korea, Republic Of (South)
  • 제조사 모회사 (2017)
    Koojoo Trading Co.
  • Source
    USFDA