Events

Device Recall 3M Comply EO Chemical Indicators Strips 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 3M Company / Medical Division 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
    46950
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1568-2008
  • 사례 시작날짜
    2008-03-19
  • 사례 출판 날짜
    2008-08-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68615
  • 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
    Physical/Chemical Sterilization Process Indicator - Product Code JOJ
  • 원인
    A production specification discrepancy may cause the indicators to show an inaccurate result, which could incorrectly lead customers to conclude the sterilization cycle was adequate.
  • 조치
    Customers and Distributors were each sent a "Voluntary Product Recall" letter dated 3/17/08 on 3/19/08. The letter states that use of the affected product should immediately be discontinued, stocks should be checked for any remaining inventory, and reprocess any unused packs using the product not from the affected lot or from an alternative supplier. The letter requested consignees to notify 3M whether the facility has affected product or not by sending the "Product Return Form". Replacements will be provided to those with affected products remaining in their stock.

Device

Device Recall 3M Comply EO Chemical Indicators Strips
  • 모델명 / 제조번호(시리얼번호)
    2008-02AA, 2008-03AA, 2008-04AA, 2008-05AA, 2008-08AA, 2008-10AA,  2008-10AB, 2008-12AA, 2009-02AA, 2009-02AB, 2009-04AA, 2009-05AA,  2009-08AA, 2009-09AA.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution --- including states of AL, AR, AZ, CA, CO, CT,DC, DE, FL, GA,HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS,MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
  • 제품 설명
    3M Comply EO Chemical Indicators Strips, Catalog #1251 || The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625 inches wide by 8 inches long) printed with a chemical indicator ink that turns from red to green when exposed to ethylene oxide (EO) sterilization process. It is designed to indicate whether EO has penetrated to the point of placement of the strip, usually the center of the pack. Each strip is perforated at the center if a shorter internal chemical indicator is preferred. An internal chemical indicator should be used inside each pack to be sterilized. || 3M Health Care || 3M Center Bldg 275-4E-011, St. Paul, MN 55144-1000
  • Manufacturer
    3M Company / Medical Division

Manufacturer

3M Company / Medical Division
  • 제조사 주소
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, South St Paul MN 55144
  • 제조사 모회사 (2017)
    3m Company
  • Source
    USFDA