Events

Recall of Device Recall IVF Pasteur Pipettes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Humagen Fertility Diagnostics, Inc..

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
    38348
  • Event Risk Class
    Class 2
  • Event Number
    Z-1220-2007
  • Event Initiated Date
    2007-05-08
  • Event Date Posted
    2007-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53469
  • 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
    embryo transfer pipettes - Product Code MQK
  • Reason
    Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.
  • Action
    The recalling firm notified consignees by phone and e-mail on 05/07/07. International consignees were advised to discard product for replacement.

Device

Device Recall IVF Pasteur Pipettes
  • Model / Serial
    160306022 EXP 1/22/2010 160306046 EXP 2/15/2010 160306065 EXP 3/6/2010
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled product was distributed to 2 direct accounts in IL and to 6 international distributors in United Kingdom, Greece, Australia, United Arab Emirates, the Netherlands, and Israel.
  • Product Description
    IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagnostics, Inc. 2400 Hunter's Way Charlottesville, VA 22911***
  • Manufacturer
    Humagen Fertility Diagnostics, Inc.

Manufacturer

Humagen Fertility Diagnostics, Inc.
  • Manufacturer Address
    Humagen Fertility Diagnostics, Inc., 2400 Hunters Way, Charlottesville VA 22911-7930
  • Source
    USFDA