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/ Manufacturer |
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 |
Other |
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
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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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