BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-1568-2008 · Initiated March 19, 2008

    Recall

    Recall Number
    Z-1568-2008
    Event Number
    46950
    FEI Number
    2110898
    Product Code
    JOJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 19, 2008
    Posted
    August 8, 2008
    Terminated
    March 1, 2012
    Address
    Bldg 275-05-W-06 3M Company Medical Division 3M Center, South St Paul, MN, 55144

    Description

    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

    Reason

    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.

    Action

    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.

    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.

    Quantity

    12,998 cases ( 4 boxes per case & 480 strips per box))