Events

Device Recall HOLDEX SingleUse Holder PP 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Greiner Bio-One North America, 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
    59352
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2957-2011
  • 사례 시작날짜
    2011-06-29
  • 사례 출판 날짜
    2011-08-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-11-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102344
  • 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
    Hypodermic Needle Holder, Single Lumen - Product Code FMI
  • 원인
    At removal of the tube from the holder, the needle may dislodge and blood spill can occur.
  • 조치
    Greiner Bio-One North America, Inc. sent a "Recall HOLDEX Single Use Holder PP" letter dated June 29, 2011 to all affected customers. The letter instructed customers stop distributing the product immediately. A Product Disposition form was provided to be completed and returned to Greiner Bio-One at which time upon receipt, arrangements for product return to Greiner Bio-One will be made for replacement or credit. They were requested to provide a list of their customers to Greiner Bio-One that received the affected item. For additional information call Greiner Bio-One at (888) 266-3883.

Device

Device Recall HOLDEX SingleUse Holder PP
  • 모델명 / 제조번호(시리얼번호)
    Item number: 450263D, Lot number A1008033
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of CA, GA, IL, KS, MA, IL, PA and VA.
  • 제품 설명
    HOLDEX Single-Use Holder PP closed pack. || Greiner Bio-One Austria Gmbh. || A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless steel needle on the underside of the holder, recommended for use with commercially available butterfly and luer needles in routine venipuncture procedures.
  • Manufacturer
    Greiner Bio-One North America, Inc.

Manufacturer

Greiner Bio-One North America, Inc.
  • 제조사 주소
    Greiner Bio-One North America, Inc., 4238 Capital Dr, Monroe NC 28110
  • 제조사 모회사 (2017)
    Greiner Holding Ag
  • Source
    USFDA