Events

Recall of 100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box. Product No. MFS102

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maximus Medical Products 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
    27697
  • Event Risk Class
    Class 2
  • Event Number
    Z-0152-04
  • Event Initiated Date
    2003-10-30
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30371
  • 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
    Set, Administration, Intravascular - Product Code FPA
  • Reason
    Mislabeled with wrong drop size drip chamber specification.
  • Action
    The firm called and sent fax recall letters on or about 10/30/2003. Labels were shipped and applied to stock in question. Recall is complete.

Device

100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 5...

Manufacturer

Maximus Medical Products Inc
  • Manufacturer Address
    Maximus Medical Products Inc, 3183 Airway Ave Bldg E, Costa Mesa CA 92626
  • Source
    USFDA