Events

Recall of WOLFPAK REDIFLO ELASTOMERIC INFUSION PUMP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wolf Medical Supply 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
    60316
  • Event Risk Class
    Class 1
  • Event Number
    Z-0267-2012
  • Event Initiated Date
    2011-10-20
  • Event Date Posted
    2011-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105019
  • 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
    ELASTOMERIC INFUSION PUMP - Product Code MEB
  • Reason
    Redi-flo elastomeric infusion pumps may have a higher flow rate than specified (more than +15%).
  • Action
    On 10/20/2011 Wolf Medical Supply Inc., customers were notified by telephone and email. Product was distributed to end users.

Device

WOLFPAK REDIFLO ELASTOMERIC INFUSION PUMP
  • Model / Serial
    Lot 90225 Exp 01/2012,  Lot 90514 Exp 04/2012,  Lot 90517 Exp 04/2012.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution, including Puerto Rico.
  • Product Description
    Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 60 mL, FLOW RATE 2mL/Hr, Model # CT-0020-060 Item # RFC060020. Manufactured by Medpro International (Thailand) Ltd.
  • Manufacturer
    Wolf Medical Supply Inc.

Manufacturer

Wolf Medical Supply Inc.
  • Manufacturer Address
    Wolf Medical Supply Inc., 13951 Nw 8th St, Fort Lauderdale FL 33325-6251
  • Manufacturer Parent Company (2017)
    Wolf Medical Supply Inc.
  • Source
    USFDA