Events

Recall of Device Recall Hamilton Soft Grip Pipettes, 1 ml fixed volume

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hamilton Co.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    48425
  • Event Risk Class
    Class 2
  • Event Number
    Z-2232-2008
  • Event Initiated Date
    2008-05-07
  • Event Date Posted
    2008-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71359
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pipette - Product Code JQW
  • Reason
    Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity.
  • 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.

Device

Device Recall Hamilton Soft Grip Pipettes, 1 ml fixed volume
  • Model / Serial
    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
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product distributed throughout the US and to Puerto Rico, New Zealand, Australia, Japan and Canada.
  • Product Description
    Hamilton Soft Grip Pipettes, 1 ml fixed volume, model number 55019-19 || Product is indicated for manual pipetting.
  • Manufacturer
    Hamilton Co

Manufacturer

Hamilton Co
  • Manufacturer Address
    Hamilton Co, 4970 Energy Way, Reno NV 89502-4123
  • Source
    USFDA