Events

Device Recall ProLite Mesh 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Atrium 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
    79293
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0712-2018
  • 사례 시작날짜
    2017-11-22
  • 사례 출판 날짜
    2018-02-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161830
  • 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
    Mesh, surgical, polymeric - Product Code FTL
  • 원인
    An incorrect prolite mesh configuration was packaged as product code 1010306-06, with lot number 412298. prolite mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.
  • 조치
    Please examine inventory to determine if you have any of the affected products listed on page 1. If so, please remove affected products, quarantine them, and place in a secure location. If you have affected product, please contact Getinge Customer Service at internationalcs@atriummed.com for a Return Authorization (RA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents, and using the shipping instructions provided, arrange for pick up with the designated delivery service provider. Please complete and sign the enclosed Urgent Medical Device Field Safety Notice to acknowledge receipt. Return the completed form to the following e-mail address: MESH2017@getinge.com For further questions, please call (973) 709-7654.

Device

Device Recall ProLite Mesh
  • 모델명 / 제조번호(시리얼번호)
    Product Code/REF 1010306-06 Lot Number/LOT: 412298
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Internationally to Spain only.
  • 제품 설명
    ProLite Mesh - mesh, surgical, polymeric || ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • 제조사 주소
    Atrium Medical Corporation, 40 Continental Blvd, Merrimack NH 03054-4332
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA