Events

Recall of Device Recall FemoStop Reprocessed Femoral Compression Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ascent Healthcare Solutions, 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
    56157
  • Event Risk Class
    Class 2
  • Event Number
    Z-2196-2010
  • Event Initiated Date
    2010-06-23
  • Event Date Posted
    2010-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92761
  • 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
    Clamp, vascular, reprocessed. - Product Code NMF
  • Reason
    The femostop devices may fail to inflate or hold pressure. a separation between the dome and arch base prevents the device from maintaining pressure when inflated.
  • Action
    Ascent sent an urgent medical device voluntary recall notification Letter and Response Form to each consignee on June 25, 2010. Consignees were requested to immediately examine their inventory of Ascent Reprocessed FemoStop devices with lot numbers located on an attached list; remove and quarantine all affected devices; complete the attached Recall Effectiveness Check Form; ship all affected product back to Ascent using the address indicated in the letter, and fax a completed Recall Effectiveness Check Form to 480-763-5350.

Device

Device Recall FemoStop Reprocessed Femoral Compression Device
  • Model / Serial
    Lot: 869509, 878402, 878439, 879762, 879990, 880274.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed to 8 consignees (end users/hospitals) located in VA, CA, FL, MI, WA.
  • Product Description
    ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.
  • Manufacturer
    Ascent Healthcare Solutions, Inc.

Manufacturer

Ascent Healthcare Solutions, Inc.
  • Manufacturer Address
    Ascent Healthcare Solutions, Inc., 5307 Great Oak Drive, Lakeland FL 33815-3113
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA