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
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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
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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 |
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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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