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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Attest

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  Class 2 Device Recall 3M Attest see related information
Date Initiated by Firm October 24, 2003
Date Posted December 18, 2003
Recall Status1 Terminated 3 on February 09, 2005
Recall Number Z-0236-04
Recall Event ID 27465
Product Classification Indicator, Biological Sterilization Process - Product Code FRC
Product 3M Attest 1264 Biological Indicators, in boxes of 100 per box
Code Information Lot numbers 2005-07 DR, 2005-07 DS, 2005-07 DT, 2005-07 DU, 2005-08 DA, 2005-08 DB, 2005-08 DC, 2005-08 DN, and 2005-08 DO
Recalling Firm/
Manufacturer		 3m Health Care
3m Center
Saint Paul MN 55144-1001
For Additional Information Contact Cynthia Lamarucciola
651-733-7605
Manufacturer Reason
for Recall		 The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation.
FDA Determined
Cause 2		 Other
Action The firm conducted a field correction which began on 10/24/03. They provided revised labeling for the product. Letters, dated October 24, 2003, were sent to consignees. The letters had a description of the problem, instructions for doing the relabeling in the field, and recommendations for users of the product.
Quantity in Commerce 9592 boxes of 100 biological indicators per box
Distribution The product was distributed nationwide in the United States and worldwide.
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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