Events

Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medline International Two Australia Pty Ltd 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
    RC-2013-RN-00706-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-07-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00706-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Edwards lifesciences has notified medline that they are conducting a recall of certain lot numbers of the edwards lifescience suction wand, which is included in medline's cardiac pack. edwards discovered plastic particulate inside the sterile pouch and within the internal diameter of the rigid suction wands. the particulate ranged from 0.26 to 0.41 (6.6 to 10.4mm) in size. particulate not detected during the preparation of the device may pose a risk as it may enter into the pericardium and could cause abrasions to the surface of the heart.
  • 조치
    Customers are asked to inspect all inventory and return affected packs to Medline.

Device

Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand)
  • 모델명 / 제조번호(시리얼번호)
    Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand) Product Code: SCVPEMO01H (which includes Suction Wand Model Code: S099)Lot Numbers: CS1273342, CS1274530, CS1275921, CS1276983, CS1277145, CS1279180, CS1279527, CS1381863, CS1381982, CS1383487, CS1384082, CS1384586 and CS1385127ARTG Number: 136870
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd