Events

HipVac and KVac 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ArthroCare Medical Corporation 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
    69667
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0579-2015
  • 사례 시작날짜
    2014-10-27
  • 사례 출판 날짜
    2014-12-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131297
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • 원인
    Potential breach of sterile barrier due to defective product tray.
  • 조치
    The firm notified their consignees on 10/29/14 via letter with a response form included. The letter requested the consignees discontinue use of the device and return it to the vendor.

Device

HipVac and KVac
  • 모델명 / 제조번호(시리얼번호)
    Model Number ASHA4730-01 (HipVac) lot numbers: 1021255, 1021620, 1022188, 1022482, 1022636, 1023089, 1024067, 1025482, 1025480, 102481, 1025764, 1025765, 1026875, 1027163, 1027702, 1028327, 1029265, 1030025, 1031353, 1031759, 1031760, 1032765, 1032766, 1033773, 1033974, 1034227, 1034451, 1035036, 1035295, 1038550, 1039318, 1039903, 1042371, 1042370, 1043421, 1044678, 1045361, 1046599, 1047067, 1050441, 1053407, 1053408, 1052669, 1054471, 1056213, 1057010, 1055117, 1058810, 1058291, 1059396, 1061007, 1061008, 1064276, 1064641, 1065989, 1070710, 1070711, 1071321, 1071322, 1071360, 1071361, 1073431, 1073432, 1074079, 1074140, 1076027, 1077459, 1078013, 1078911  Model Number ASHA5050-01 (KVac) lot numbers: 1044887, 1050012, 1053720, 1054965, 1055700, 1068390, 1068391, 1068392, 1068393, 1076028, 1078916, 1078918
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) and the countries of Austria, Australia, Belgium, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Ireland, Malaysia, Netherlands, Norway, Poland, Spain, South Africa, Sweden, Switzerland, Turkey, and UK.
  • 제품 설명
    Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. || The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
  • Manufacturer
    ArthroCare Medical Corporation

Manufacturer

ArthroCare Medical Corporation
  • 제조사 주소
    ArthroCare Medical Corporation, 7000 W William Cannon Dr, Austin TX 78735-8509
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA