Events

Recall of Device Recall Flexipet Manipulation pipette 300 micron

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook Vascular 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
    48629
  • Event Risk Class
    Class 2
  • Event Number
    Z-2177-2008
  • Event Initiated Date
    2008-03-02
  • Event Date Posted
    2008-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71758
  • 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 MQH
  • Reason
    Mislabeled - 300 micron flexipets labeled as 130 micron and vice versa.
  • Action
    The recalling firm issued an Urgent product Recall letter on 3/3/08. The letter informed the customers of the problem and that the pouch is correctly labeled. Customers were instructed to return product and notify any sub accounts. Please contact Cook Vascular at 1-724-845-8621 for assistance.

Device

Device Recall Flexipet Manipulation pipette 300 micron
  • Model / Serial
    Lot number N74173
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI.
  • Product Description
    Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes.
  • Manufacturer
    Cook Vascular Inc.

Manufacturer

Cook Vascular Inc.
  • Manufacturer Address
    Cook Vascular Inc., 1186 Montgomery Ln, Vandergrift PA 15690-6065
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA