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U.S. Department of Health and Human Services

Class 3 Device Recall Microliter CORE Tips

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  Class 3 Device Recall Microliter CORE Tips see related information
Date Initiated by Firm April 09, 2009
Date Posted September 09, 2009
Recall Status1 Terminated 3 on January 04, 2010
Recall Number Z-1999-2009
Recall Event ID 52667
Product Classification Microliter CO-RE Tips - Product Code JTC
Product 300 Microliter CO-RE Tips for use with Microlab STAR, manufactured by Hamilton Company, Reno, NV.

Product is a disposable product used with Microlab STAR series Instruments, which are microtiter diluting and dispensing devices.
Code Information Part Number 235950 (case containing 11,520 tips), Lot Number 2950441 and Part Number 235902 (case containing 5,760 tips), Lot Number 2950461.
Recalling Firm/
Manufacturer
Hamilton Co
4970 Energy Way
Reno NV 89502-4123
For Additional Information Contact
775-858-3000 Ext. 236
Manufacturer Reason
for Recall
Product Defect-- some tips from the mold cavity 28 are too short and do not always aspirate or dispense liquid correctly.
FDA Determined
Cause 2
Process control
Action The firm initiated the recall on April 10, 2009, and issued notification to consignees via certified mail and e-mail. Customers were instructed to return the affected product to the Hamilton Company. A fax-back form was supplied with each notification. Direct questions about the recall to the Hamilton Company by calling 1-775-858-3000, extension 236.
Quantity in Commerce 20 cases of Part 235950 and 27 cases of Part 235902.
Distribution Worldwide Distribution -- US (states of DE, NJ, PA, MA and CA), New Zealand and Japan.
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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