Events

Recall of Device Recall Pasteur Pipets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ORIGIO, 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
    68592
  • Event Risk Class
    Class 2
  • Event Number
    Z-1946-2014
  • Event Initiated Date
    2014-06-20
  • Event Date Posted
    2014-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128281
  • 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
    pipets for IVF - Product Code MQK
  • Reason
    Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration.
  • Action
    Field Safety Corrective Action / Urgent Product Recall letter dated June, 2014.

Device

Device Recall Pasteur Pipets
  • Model / Serial
    CODE: Model #s: PP-5.75-90, PP-9-90, PP-5.75-90PL, PP-9-90PL. Lots with labeled expiry date of May 2, 2015, or later.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US Nationwide, Canada, Australia, Barbados, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Great Britain, Greece, India, Italy, Japan, Jordan, Malaysia, Netherlands, Peru, Russia, Singapore, South Africa, Spain, Taiwan, Turkey, and United Arab Emirates.
  • Product Description
    Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. || Model numbers: || PP-5.75-90 || PP-9-90 || PP-5.75-90PL || PP-9-90PL
  • Manufacturer
    ORIGIO, Inc

Manufacturer

ORIGIO, Inc
  • Manufacturer Address
    ORIGIO, Inc, 2400 Hunters Way, Charlottesville VA 22911-7930
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA