Events

Device Recall Mediline Industries, Inc. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Unimed Surgical Products, 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
    61982
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2290-2012
  • 사례 시작날짜
    2010-06-16
  • 사례 출판 날짜
    2012-08-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111223
  • 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
    On 6/16/2010 unimed surgical products, inc., 10401 belcher road, largo, fl 33777 initiated a recall of the medline industries, inc. electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
  • 조치
    Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated June 4, 2010 to Medline Industries, Inc. The letter identified the affected product, problem and actions to be taken. Medline was instructed to quarantine any undistributed product and notify its customers of the recall. For further information, contact Unimed Surgical Product, Inc. by phone 800-531-2627 or FAX 800-886-1225.

Device

Device Recall Mediline Industries, Inc.
  • 모델명 / 제조번호(시리얼번호)
    Lot # 03059-03
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution - including the state of IL.
  • 제품 설명
    Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" || Part # ESE1651 -- Lot # 03059-03 || Product Usage: Intended for cutting and coagulation of soft tissue.
  • Manufacturer
    Unimed Surgical Products, Inc.

Manufacturer

Unimed Surgical Products, Inc.
  • 제조사 주소
    Unimed Surgical Products, Inc., 10401 Belcher Rd South, Largo FL 33777-1415
  • 제조사 모회사 (2017)
    Unimed Surgical Products Inc
  • Source
    USFDA