Events

Safety Glide 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & 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
    33966
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0403-06
  • 사례 시작날짜
    2005-10-25
  • 사례 출판 날짜
    2006-01-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-06-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42823
  • 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
    Syringe, Antistick - Product Code MEG
  • 원인
    Safety mechanisms on the syringes are rotating too freely. this can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.
  • 조치
    Recall notifications were sent to all direct consignees and potential end users on 10/25/2005 via UPS second day air.

Device

Safety Glide
  • 모델명 / 제조번호(시리얼번호)
    Reference Number 305946: Product Description: 1ml 26G Blister Lot #: 5201856; 5175735; 5146697; 5143522; 5111315; 5082352; 5052279; 5020322; 4344951; 4323197.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed nationwide to 450 consignees composed of wholesalers, hospitals, and medical supply distributors. There is a Canadian customer, Dufort & Lavigne, Montreal, Quebec, Canada. Government customers include VAMC New Orleans, New Orleans, LA; Fox Army Health Center, Redstone Arsenal, AL; Moncrief Army Community Hospital, Columbia, SC; US Naval Med. Ctr., Portsmouth, VA; USAF Hill AFB 649 Medical Group, Hill Air Force Base, UT; VAMC Ann Arbor, MI; VAMC East Orange, NJ; VAMC Tuskegee, AL; McDonald Army Community Hospital, Newport News, VA.
  • 제품 설명
    BD 1 mL BD Safety Glide Tuberculin syringe with 26 G x 3/8 in. BD needle.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • 제조사 주소
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA