Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1999-2009

300 Microliter CO-RE Tips for use with Microlab STAR, manufactured by Hamilton Company, Reno, NV. Product is...

Hamilton Co / initiated 2009-04-09 / Terminated / root cause: manufacturing process

Hamilton Co began a recall of 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... on . The reason FDA records is "Product Defect-- some tips from the mold cavity 28 are too short and do not always aspirate or dispense liquid correctly". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1999-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hamilton Co
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.
Product code
JTC Device, Microtiter Diluting/Dispensing
Reason for recall
Product Defect-- some tips from the mold cavity 28 are too short and do not always aspirate or dispense liquid correctly.
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and lots
Part Number 235950 (case containing 11,520 tips), Lot Number 2950441 and Part Number 235902 (case containing 5,760 tips), Lot Number 2950461.