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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 Device Recall 3M Comply EO Chemical Indicators Strips see related information
Date Initiated by Firm March 19, 2008
Date Posted August 08, 2008
Recall Status1 Terminated 3 on March 01, 2012
Recall Number Z-1568-2008
Recall Event ID 46950
Product Classification Physical/Chemical Sterilization Process Indicator - 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 MN 55144
For Additional Information Contact
651-733-1000
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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