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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Comply EO Chemical Indicators Strips

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 Class 2 Recall
3M Comply EO Chemical Indicators Strips
see related information
Date Posted August 08, 2008
Recall Status1 Open
Recall Number Z-1568-2008
Recall Event ID 46950
Product Classification Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
Product 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
Code Information 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,
Recalling Firm/
Manufacturer
3M Company / Medical Division
3M Center, Bldg 275-05-W-06
South St Paul, Minnesota 55144
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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.
Quantity in Commerce 12,998 cases ( 4 boxes per case & 480 strips per box))
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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