Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2232-2008

Hamilton Soft Grip Pipettes, 1 ml fixed volume, model number 55019-19 Product is indicated for manual...

Hamilton Co / initiated 2008-05-07 / Terminated / root cause: design

Hamilton Co began a recall of Hamilton Soft Grip Pipettes, 1 ml fixed volume, model number 55019-19 Product is indicated for manual pipetting on . The reason FDA records is "Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2232-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hamilton Co
Product
Hamilton Soft Grip Pipettes, 1 ml fixed volume, model number 55019-19 Product is indicated for manual pipetting.
Product code
JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall
Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity
Root cause tag
design
FDA root cause
Device Design
Action
Recall initiated May 7 2008. Notification issued via certified overnight mail explains the problem and instructs customers to inventory the affected pipettes. The firm will contact its customers and supply replacement lower-body assemblies, repair instructions and return information so that affected parts can be returned to Hamilton. A fax-back form is supplied with each notification. Responses will be tracked. Contact Hamilton Co. at 1-775-558-3000 for assistance.
Quantity in commerce
48 units
Distribution
Product distributed throughout the US and to Puerto Rico, New Zealand, Australia, Japan and Canada.
Product codes and lots
serial numbers 64133, 64137, 64139, 64145, 64148, 64156, 64163, 64171, 64175, 64180, 64189, 64192, 64193, 64193, 64198, 64199, 64200, 64202, 64203, 64205, 64211, 64212, 64216, 64224, 64225, 64921, 65072, 65081, 65099, 65105, 65107, 65110, 65140, 65141, 65151, 65159, 65160, 65163, 65164, 65172, 65486, 65501, 65517, 65540, 65585, 65599, 65619, 65629, 65658, 65699, 65934, 65951, 65969, 65972, 65992, 66764, 66783, 66788, 66793, 66892, 66897, 66902, 66972, 66982, 66991, 66999, 67001, 67031, 67035, 67044, 67054, 67055, 67059, 67082, 67084, 67091, 67094, 67098, 67120, 67130, 67145, 67162, 67167, 67170, 67175, 67176, 67190, 67191, 67198, 67224, 67237, 67247, 67258, 67260, 67269, 67278, 67280, 67282, 67283, and 67285