Events

Recall of Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing, latex free, catalog # 55050. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vital Concepts, 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
    27694
  • Event Risk Class
    Class 2
  • Event Number
    Z-0259-04
  • Event Initiated Date
    2003-11-07
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30499
  • 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
    Tube, Aspirating, Flexible, Connecting - Product Code BYY
  • Reason
    The probe may separate from the cannula.
  • Action
    Recall letters dated November 7, 2003 were sent to each consignee asking them to return any remaining products in inventory or in the field.

Device

Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing, latex free...
  • Model / Serial
    lot 50904971.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Arizona, Illinois, Indiana, Michigan and Pennsylvania.
  • Product Description
    Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing, latex free, catalog # 55050. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan.
  • Manufacturer
    Vital Concepts, Inc.

Manufacturer

Vital Concepts, Inc.
  • Manufacturer Address
    Vital Concepts, Inc., 5090 Kendrick Ct Se, Grand Rapids MI 49512-9649
  • Source
    USFDA