Events

Device Recall Automatic Cutting Needles 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Remington Medical 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
    63070
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0028-2013
  • 사례 시작날짜
    2012-08-29
  • 사례 출판 날짜
    2012-10-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112454
  • 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
    Instrument, biopsy - Product Code KNW
  • 원인
    Sterility of the product may be compromised.
  • 조치
    The firm, Remington Medical, Inc., sent an "URGENT - MEDICAL DEVICE RECALL" letter dated August 29, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the products; complete and return the FaxBack form via Fax to: Quality Engineer Remington Medical, Inc., at 770-887-0732 or email: tracyw@remmed.com; and call the Quality Engineer or customer service at (800) 989-0057 ext 233 to obtain a RGA number and have a call tag issued. Should you have any questions, please do not hesitate to call the Quality Engineer at (800) 989-0057 ext 233.

Device

Device Recall Automatic Cutting Needles
  • 모델명 / 제조번호(시리얼번호)
    NAC-1820M, Lot number: 121003
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.
  • 제품 설명
    Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. || Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
  • Manufacturer
    Remington Medical Inc.

Manufacturer

Remington Medical Inc.
  • 제조사 주소
    Remington Medical Inc., 6830 Meadowridge Ct., Alpharetta GA 30005
  • 제조사 모회사 (2017)
    Remington Medical, Inc.
  • Source
    USFDA