Events

Applied GelPort Laparoscopic Hand Access Device, Model C8004 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Applied Medical Resources Corp 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
    33856
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0151-06
  • 사례 시작날짜
    2005-10-17
  • 사례 출판 날짜
    2005-11-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-04-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42593
  • 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
    Laparoscope, General & Plastic Surgery - Product Code GCJ
  • 원인
    The applied gelport laparoscopic hand access device, model c8004. product is being recalled due to an incorrect component. the incorrect wound retractor base was packaged with the kit.
  • 조치
    The recall was initiated on October 14,2005. Applied Medical will contact all customers involved in the recall via overnight FEDEX / UPS. A follow-up communication concerning the recall notification letter will be sent to each of the customers who have not responded with 30 days.Applied is requesting product lot listed in the notification be returned to Applied Medical. All product involved in the recall will be destroyed.

Device

Applied GelPort Laparoscopic Hand Access Device, Model C8004
  • 모델명 / 제조번호(시리얼번호)
    Lot Number / Expiration Date:1001381/2008-08 UPC Codes:C8004 +H699C80040K
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath. Impervious Sleeve, Skin Marker. Sterile Lubricant, and Incision Template.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • 제조사 주소
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • 제조사 모회사 (2017)
    Applied Medical Corporation
  • Source
    USFDA