Events

Recall of ParaSlyde, Controlled descent device.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Paramed Systems.

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
    53339
  • Event Risk Class
    Class 2
  • Event Number
    Z-0568-2010
  • Event Initiated Date
    2008-10-29
  • Event Date Posted
    2009-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85297
  • 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
    Stretcher, hand-carried - Product Code FPP
  • Reason
    Possible partial board disassembly due to inadequate webbing attachment.
  • Action
    Customers were notified by letter and phone during 10/20/2008 and 10/29/2008 to schedule visits by Paramed to correct the devices.

Device

ParaSlyde, Controlled descent device.
  • Model / Serial
    Lot number 08/219/B.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Including states of AZ, CA, FL, GA, IL, IN, KS, KY, MA, MI, MT, NY, PA, SC, TN and UT.
  • Product Description
    Paramed Polypropylene evacuation sled for non-ambulatory patients. || Hand-carried stretcher. Product 11-778-01.
  • Manufacturer
    Paramed Systems

Manufacturer

Paramed Systems
  • Manufacturer Address
    Paramed Systems, 8100 S 1300 W Ste D, West Jordan UT 84088-8307
  • Source
    USFDA