Class 2 Device Recall 3M Attest

• Date Initiated by Firm: October 24, 2003
• Date Posted: December 18, 2003
• Recall Status: Terminated on February 09, 2005
• Recall Number: Z-0237-04
• Recall Event ID: 27465
• Product Classification: Indicator, Biological Sterilization Process - Product Code FRC
• Product: 3M Attest 1264P Biological Indicators, in boxes of 25 per box
• Code Information: Lot numbers 2005-07 DW, 2005-08 DD, and 2005-08 DL
• 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: 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: 1844 boxes of 25 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.