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
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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
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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 |
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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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