Events

Device Recall DePuy Mitek FMS Irrigation Intermediary Tube Without Oneway Valve Arthroscopy tubing 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DePuy Mitek, Inc., a Johnson & Johnson Co. 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
    57385
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1947-2011
  • 사례 시작날짜
    2010-12-03
  • 사례 출판 날짜
    2011-04-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-04-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96023
  • 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
    Arthroscope - Product Code HBX
  • 원인
    Product sterility may be compromised due to breach in sterile packaging.
  • 조치
    Depuy Mitek sent an Urgent Voluntary Product Recall letter dated December 2, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to isolate all inventory of the affected product and call 1-800-382-4682, PROMPT 3, for return good authorization and replacement product. Customers were instructed to return all identified affected product to: DePuy Mitek ATTN: Recall Coordinator 50 Scotland Boulevard Bridgewater, MA 02324 Record their assigned return material authorization (RMA) number on the outer shipping box. Use the Prepaid Federal Express shipping label for the return of the product. Include a photo copy of the completed business reply form. For questions or concerns call 1-800-382-4682, PROMPT 3.

Device

Device Recall DePuy Mitek FMS Irrigation Intermediary Tube Without Oneway Valve Arthroscopy tubing
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: 1060790 BBBA1001N BBBA1005C BBBA1006G BBBA1014C
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia.
  • 제품 설명
    DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing || Product Code: 281103 || Fluid Tissue Management
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • 제조사 주소
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Dr, Raynham MA 02767
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA