Device Recall Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Microline Surgical, Inc. 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
    59469
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3085-2011
  • 사례 시작날짜
    2011-07-18
  • 사례 출판 날짜
    2011-08-29
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-09-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Mislabeled: renew product number 3262 (long fenestrated grasper) was packaged and labeled as product number 3642 (super-atrau fenestrated grasper). renew product number 3642 (super-atraumatic fenestrated grasper) was packaged and labeled as 3262 (long fenestrated grasper.
  • 조치
    Microline Surgical sent a RECALL NOTICE letter dated July 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine product subject to the recall. If customers further distributed the product, customers should identify their accounts and notify them immediately of the product recall. Customers were instructed to contact Microline Customer Service to obtain a Return Authorization Number for return of the recalled item. Customers were asked to complete and return the enclosed Recall Return Response Form as soon as possible. For any questions customers were instructed to call the Regulatory Affairs Manager at 978-867-1726.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 00105332 Expiration date: 5-2016
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including FL, MI, MN, TN and WI and the countried of Canada, The Netherlands, Thailand, UK, Norway, and Italy.
  • 제품 설명
    Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip || Ref: 3262 || The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula
  • Manufacturer

Manufacturer

  • 제조사 주소
    Microline Surgical, Inc., 800 Cummings Ctr Ste 166t, Beverly MA 01915-6171
  • 제조사 모회사 (2017)
  • Source
    USFDA