Events

Recall of Device Recall ONQ PainBuster

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by I-Flow Corporation.

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
    36984
  • Event Risk Class
    Class 2
  • Event Number
    Z-0358-2007
  • Event Initiated Date
    2006-11-29
  • Event Date Posted
    2007-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49710
  • 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
    Infusion Pump - Product Code MEB
  • Reason
    The pump flow rate labeling may not match the package labeling. the label on filter may not match the label on the top of the pump or the package labeling.
  • Action
    A Recall Notification Letter was faxed to affected customers on November 29, 2006. Affected customers were notified of the identity of product subject to recall, the reason for recall, and instructed to quarantine immediately any remaining inventory. A Customer Response (FAX back) form was included with the Recall Notification Letter (dated November 29, 2006). Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt. The fax back form indicates the quantity of remaining product from each lot the customer may have.

Device

Device Recall ONQ PainBuster

Manufacturer

I-Flow Corporation
  • Manufacturer Address
    I-Flow Corporation, 20202 Windrow Dr, Lake Forest CA 92630-8152
  • Source
    USFDA