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U.S. Department of Health and Human Services

Class 3 Device Recall 3M Attest

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  Class 3 Device Recall 3M Attest see related information
Date Initiated by Firm January 09, 2002
Date Posted April 22, 2003
Recall Status1 Terminated 3 on May 09, 2003
Recall Number Z-0779-03
Recall Event ID 25868
Product Classification Indicator, Biological Sterilization Process - Product Code FRC
Product 3M Attest Steam Pack 1276F (biological indicator of steam sterilization for use at hospitals) .
Code Information Lot 2003-06 AE
Recalling Firm/
3m Health Care
3m Center
Saint Paul MN 55144-1001
Manufacturer Reason
for Recall
Some 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization) were labeled as 3M Attest Rapid Readout Steam Pack 1296F.
FDA Determined
Cause 2
Action A recall letter was sent to the consignees on January 8, 2002 and requested the return of the product.
Quantity in Commerce 666 cases (25 Steam Pack per case)
Distribution Distribution was nationwide in the United States. There were no U.S. government accounts.
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.