Events

Recall of Device Recall Hamilton microliter syringe

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
    35292
  • Event Risk Class
    Class 3
  • Event Number
    Z-1169-06
  • Event Initiated Date
    2006-03-28
  • Event Date Posted
    2006-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45735
  • 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
    syringe HPLC - Product Code JQW
  • Reason
    There is an error in the marking of the graduated divisions on syringes in affected lots that shows an amount that is double the actual volume of the syringe.
  • Action
    On 3/28/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

Device

Device Recall Hamilton microliter syringe
  • Model / Serial
    Lot 340007 and 342081
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide-The product was distributed to 28 U.S. consignees and 3 foreign consignees. (Canada, Switzerland, Japan)
  • Product Description
    Syringe, 62RNR 2.5 Microliter Syringe, with needle point style 3 (blunt needle point for use with HPLC injection valves and for sample pipetting) Part #: 87942.
  • Manufacturer
    Hamilton Co

Manufacturer

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