Device Recall Welcon 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nurse Assist, 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
    58021
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2274-2011
  • 사례 시작날짜
    2011-01-20
  • 사례 출판 날짜
    2011-05-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-10-25
  • 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
    Catheter, urological - Product Code KOD
  • 원인
    The trays contain triad group sterile lubricating jelly packs recalled by triad group because of the possibility of inadequate sterilization.
  • 조치
    The firm, Nurse Assist Incorporated, sent a letter dated January 20, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory immediately; quarantine the product; identify their customers and notify them at once about the product recall (Nurse Assist will provide bright labels to affix to your affected inventory); provide their customers with labels as well, and complete and return the attached RECALL ACKNOWLEGEMENT form via fax to: 817-231-1500 or mail to: Nurse Assist, Inc., 3400 Northern Cross Blvd., Forth Worth, TX 76137. Only the product and lots identified on the attached list are affected. If you have any questions or to request labels, please call Nurse Assist Customer Service Monday through Friday, from 8:00 am to 5:00 pm Central Time at 1-800-649-6800.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: 804195, 807071, 809129, 901103, 902290, 903276, 906201, 907193, 909391, 911333, 1002120, 1003395, 1005314, and 1009373.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • 제품 설명
    Case Label: REORDER NO. 7304 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Tray Label: REORDER NO. 7304 STERILE UNLESS OPENED OR DAMAGE nurse assist incorporated A6040, R2 SINGLE USE WELCON BRAND Foley Catheterization Tray With 30 mL Prefilled Syringe 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFREE CONTENTS: 1200 mL Graduated Drain Tray 30 mL Prefilled Syringe Gloves Fenestrated Drape PVP Swabsticks (3) Lube Jelly Waterproof Underpad || Intended use: The trays are urological catheter trays.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Nurse Assist, Inc, 3400 Northern Cross Blvd, Fort Worth TX 76137-3600
  • 제조사 모회사 (2017)
  • Source
    USFDA