Events

Recall of HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. 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
    27131
  • Event Risk Class
    Class 2
  • Event Number
    Z-0022-04
  • Event Initiated Date
    2003-07-11
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29248
  • 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
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered - Product Code GCY
  • Reason
    The suction valve may become stuck in the 'suction on' position under vacuum.
  • Action
    A request for product return was sent to each customer beginning on July 11, 2003.

Device

HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (sing...
  • Model / Serial
    lots 50904972 and 50905039.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan
  • Product Description
    HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
  • Manufacturer
    Vital Concepts, Inc.

Manufacturer

Vital Concepts, Inc.
  • Manufacturer Address
    Vital Concepts, Inc., 5090 Kendrick Ct. S E, Grand Rapids MI 49512
  • Source
    USFDA