Events

Device Recall SafetyDeluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables 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
    78950
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0541-2018
  • 사례 시작날짜
    2017-06-27
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160950
  • 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
    Lumbar puncture tray (adult & pediatric) - Product Code PWY
  • 원인
    Bd safetyglide needle 22ga 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
  • 조치
    On June 27, 2017, Busse Hospital Disposables distributed Urgent Medical Device Recall notices and Response Forms to their customers via courier service. A copy of the supplier's recall notice was also provided to customers. Customers were advised to conduct the following: " Discontinue use of needle immediately. " Please check your inventory and cease distribution immediately. " If you have distributed the above products, please contact your customers and inform them of this recall immediately. " Contact Busse Hospital Disposables for a Return Good Authorization number. " Complete and Return the Response Form via fax to 631-435-2849 or via email to: ijacobo@busseinc.com. Customers with questions may call 631-435-4711, ext. 254.

Device

Device Recall SafetyDeluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers/Expiration Dates: 1) 1610197/Expiration Date: 12/01/2018; 2) 1610277/Expiration Date: 03/01/2019
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 || Product Usage: || Surgical procedure
  • Manufacturer
    Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

Manufacturer

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
  • 제조사 주소
    Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables, 75 Arkay Dr, Hauppauge NY 11788-3707
  • 제조사 모회사 (2017)
    Robert Busse & Co. Inc.
  • Source
    USFDA