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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 February 27, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on December 28, 2006
Recall Number Z-0720-04
Recall Event ID 28411
Product Classification Indicator, Biological Sterilization Process - Product Code FRC
Product 3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot 2006-21, in boxes of 50 per box
Code Information Lot # 2006-01 AN
Recalling Firm/
Manufacturer		 3M Company / Medical Division
3M Center, Bldg 275-05-W-06
St Paul MN 55411
For Additional Information Contact Cynthia Lamarucciola
651-733-7605
Manufacturer Reason
for Recall		 The 3M Attest 1292 Rapid Readout Biological Indicators for steam sterilization may contain ampoules which may result in a false negative readout at 3 hours.
FDA Determined
Cause 2		 Other
Action A Product Recall Notice was sent on February 27, 2004 to consignees instructing them to discontinue use of the recalled product and return products to 3M.
Quantity in Commerce 90,000 ampoules
Distribution Nationwide throughout 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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