Events

Recall of Device Recall Medpro AccuFlo Elastomeric Infusion Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Progressive Medical 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
    59981
  • Event Risk Class
    Class 1
  • Event Number
    Z-0081-2012
  • Event Initiated Date
    2011-07-28
  • Event Date Posted
    2011-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104145
  • 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
    Pump, infusion, elastomeric - Product Code MEB
  • Reason
    The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients.
  • Action
    The firm, Progressive Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated July 28, 2011 via email and regular mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue their use; remove the products from inventory and quarantine them; inform their customers to return unused products to Progressive; return the product, and complete and return the RECALL RETURN RESPONSE FORM via fax to 314-961-5786. Progressive customer service will contact the customers to coordinate the return of the goods in question. Should you have any questions, please call 800-969-6331 or email to dsullivan@progressivemedinc.com.

Device

Device Recall Medpro AccuFlo Elastomeric Infusion Device
  • Model / Serial
    Lot #100924, Exp. 2015-08, Item CT-0020-270C
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: FL, KY, PA, VA and WY.
  • Product Description
    Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label shows the product is Manufactured By: Medpro International (Thailand) Ltd. for Medpro Corporation Pte. Ltd., Singapore. || The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
  • Manufacturer
    Progressive Medical Inc

Manufacturer

Progressive Medical Inc
  • Manufacturer Address
    Progressive Medical Inc, 11085 Gravois Industrial Ct, Saint Louis MO 63128-2012
  • Manufacturer Parent Company (2017)
    Progressive Medical Inc
  • Source
    USFDA