Device Recall 3M Comply EO Chemical Indicators Strips

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, South St Paul MN 55144
  • Société-mère du fabricant (2017)
  • Source
    USFDA