Events

Recall of IFlow ONQ with SelectAFlow Pumps

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
    59148
  • Event Risk Class
    Class 2
  • Event Number
    Z-2860-2011
  • Event Initiated Date
    2011-04-15
  • Event Date Posted
    2011-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101372
  • 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, Elastomeric - Product Code MEB
  • Reason
    The recall was initiated because i flow became aware that a small percentage of on-q pump with select a flow may develop a minor leak with a flow rate controller. there may be consequences for the patient, such as under delivery of pain medication or the need to prematurely remove the pump, which would result in loss of the pain treatment provided by the pump.
  • Action
    I-Flow Corporation sent an "Important Voluntary Market Withdrawal Notice" dated May 12, 2011 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to quarantine and return all impacted products within their facilities. Customers were instructed to respond with in 5 days of receiving the Market Withdrawal Notice and fax it to (949) 206-2663. Customers with additional questions, were instructed to call I-Flow Customer service at (800) 448-3569 (8-5pm, Pacific Standard time) or I-Flow 24 hour technical support line (800) 444-2728.

Device

IFlow ONQ with SelectAFlow Pumps
  • Model / Serial
    Model Numbers:  CB004, CB005, CB006, CB6004, CB6007, P100X2-14, P200X2-14, P270X1-7, P400X2-14, P400X1-7+5/60, P400X2-14+5/30, P600X2-14, P600X1-7D, and SAF01.   Part Numbers: 5001481,5001521,5001651,5001771,5001780,5001788,5001799, 5001807,5001808,5001809,5001810,5001811,5001830, and 5001831.   Specific lot numbers: 122215, 132435, 132464, 932165, and 962434. Also, all lot numbers that begin with:  98 (except 982631 and 982645),   99,   9A (except 9A2913),   9B,   9C,   01, 02, 03, 04, 05, 06, 07, 08, 09,   0A,   0B,   and 0C (except 0C2949 and 0C2950).
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (USA) Distribution and worldwide to: Australia, Canada, Cyprus, Italy, Germany, Finland, Greece, Israel, South Africa, Sweden, UAE, and UK.
  • Product Description
    I-Flow ON-Q with Select-A-Flow Pumps, || Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. || It is a controller that allows the user to regulate the amount of medication that is dispensed.
  • Manufacturer
    I-Flow Corporation

Manufacturer

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