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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Comply

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  Class 2 Device Recall 3M Comply see related information
Date Initiated by Firm August 09, 2006
Date Posted October 11, 2006
Recall Status1 Terminated 3 on May 25, 2007
Recall Number Z-0027-2007
Recall Event ID 36180
510(K)Number K013228  
Product Classification Chemical Indicator Strips - Product Code JOJ
Product 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Code Information Lot number 2006-12 AA through 2008-06 AB.
Recalling Firm/
Manufacturer		 3M Company / Medical Division
3M Center, Bldg 275-05-W-06
South St Paul MN 55411
Manufacturer Reason
for Recall		 3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing.
FDA Determined
Cause 2		 Other
Action The firm initiated a recall of the Comply 1248 product made with the discrepant material. Customer letters were sent on August 14, 2006. Letters notified customers of problem and instructed them to discontinue distribution or use of the product. Then to return all affected product to them.
Quantity in Commerce 6248 cases (4 boxes/case)
Distribution Nationwide.
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.
510(K) Database 510(K)s with Product Code = JOJ and Original Applicant = MINNESOTA MINING AND MFG. CO.
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