Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1203-2009

300 microliter CO-RE tips for use with Microlab STAR series instruments, Part Number 235902, 5,760 tips per...

Hamilton Co / initiated 2008-12-01 / Terminated / root cause: manufacturing process

Hamilton Co began a recall of 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... on . The reason FDA records is "Some tips may be occluded and are unable to aspirate or dispense liquid". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1203-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hamilton Co
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.
Product code
JTC Device, Microtiter Diluting/Dispensing
Reason for recall
Some tips may be occluded and are unable to aspirate or dispense liquid.
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and lots
Lot Number: 2873900.