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U.S. Department of Health and Human Services

Class 2 Device Recall 300 microliter CORE tips

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  Class 2 Device Recall 300 microliter CORE tips see related information
Date Initiated by Firm December 01, 2008
Date Posted April 17, 2009
Recall Status1 Terminated 3 on July 21, 2009
Recall Number Z-1203-2009
Recall Event ID 50529
Product Classification Device, microtiter diluting/dispensing - Product Code JTC
Product 300 microliter CO-RE tips for use with Microlab STAR series instruments, Part Number 235902, 5,760 tips per case, manufactured by Hamilton Company, Reno, NV.

The products are a disposable product that are used with the Microlab STAR series instruments, which are microtiter diluting and dispensing devices.
Code Information Lot Number: 2873900.
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		 Some tips may be occluded and are unable to aspirate or dispense liquid.
FDA Determined
Cause 2		 Process control
Action An "Urgent: Product Recall Letter" dated December 1, 2008 was issued to consignees via certified mail and e-mail. The letter described the problem and potential effects of use. Consignees were instructed to complete the enclosed "Hamilton Company Product Recall Questionnaire" and return it via e-mail or fax (775-856-7259) to the Hamilton Company. After receipt of the completed questionnaire, the firm's Customer Service Department will contact consignees to provide Returned Material Authorization information for returning affected product. Direct questions to the Hamilton Company at 775-858-3000, ext. 236.
Quantity in Commerce 28 cases
Distribution Nationwide Distribution -- MA, CA, MN, CT, and NC.
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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