Events

Progressive Medical Laparoscopic Electrode PTFE Coated Wire L Hook 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Progressive Medical 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
    64931
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1352-2013
  • 사례 시작날짜
    2013-04-12
  • 사례 출판 날짜
    2013-05-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-05-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117471
  • 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
    Product coatings require 510k approval.
  • 조치
    Progressive Medical Inc. sent an Urgent Medical Device Recall letter dated April 12, 2013, 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 segregate the affected units prior to return to Progressive Medical, Inc. If product was further distributed customers should notify their accounts of ther ecall and return the products. Customers were asked to complete and return the attached form by fax to 314-961-4535, even if they had no inventory remaining. Customers with questions were instructed to call 1-800-969-6331. For questions regarding this recall call 314-961-5786.

Device

Progressive Medical Laparoscopic Electrode PTFE Coated Wire L Hook
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 071212-06 and 082712-13
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.
  • 제품 설명
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 33cm Length, Product number P0100 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. || Electrodes used in Electrosurgeries
  • Manufacturer
    Progressive Medical Inc

Manufacturer

Progressive Medical Inc
  • 제조사 주소
    Progressive Medical Inc, 997 Horan Dr, Fenton MO 63026-2401
  • 제조사 모회사 (2017)
    Progressive Medical Inc
  • Source
    USFDA