Events

Recall of Device Recall Medamicus FlowGuard

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MedAmicus,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
    26475
  • Event Risk Class
    Class 2
  • Event Number
    Z-0967-03
  • Event Initiated Date
    2003-06-06
  • Event Date Posted
    2003-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27744
  • 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
    Introducer, Catheter - Product Code DYB
  • Reason
    Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
  • Action
    The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products.

Device

Device Recall Medamicus FlowGuard
  • Model / Serial
    Lot Number W24369
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
  • Product Description
    Medamicus FlowGuard 16 FR Valved Peelable Venous Introducer, 5 units per shelf box, Part Number 10684-003
  • Manufacturer
    MedAmicus,Inc

Manufacturer

MedAmicus,Inc
  • Manufacturer Address
    MedAmicus,Inc, 15301 Highway 55 West, Plymouth MN 55447
  • Source
    USFDA