Events

Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116 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
    57702
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1505-2011
  • 사례 시작날짜
    2010-09-10
  • 사례 출판 날짜
    2011-03-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97036
  • 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
    Applied medical is conducting a voluntary recall of specific lot numbers of the direct drive laparoscopic clip applier, model number ca090, due to a potential defect in the jaws, possibly resulting in jaw breakage.
  • 조치
    Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.

Device

Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116
  • 모델명 / 제조번호(시리얼번호)
    LOT NUMBER(S): 1121989
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.
  • 제품 설명
    Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
  • 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