Events

Recall of Device Recall EKOS Cart

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

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
    75100
  • Event Risk Class
    Class 2
  • Event Number
    Z-2890-2016
  • Event Initiated Date
    2016-08-22
  • Event Date Posted
    2016-09-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149355
  • 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
    Stand, infusion - Product Code FOX
  • Reason
    Casters on the ekos carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
  • Action
    The firm, EKOS, sent an "URGENT FIELD SAFETY ACTION" letter dated August 22, 2016 to its customers. The letters were sent to customers informing them of the field safety action, how to identify the affected carts at their facility and instructing customers locate the cart, quarantine it and do not use the cart for any procedures. A representative from EKOS Corporation will be contacting customers in the near future to arrange a date and time when the cart at a facility can be inspected and any affected caster(s) replaced. As the cart is inspected, it will be tagged to easily identify it and confirm it has been inspected and repaired as necessary. Customers will be provided with a copy of the inspection/repair form for the cart they inspect. Please retain that form for records. If customers have any questions, please contact EKOS Customer Service at 1-888-400-3567 or your local EKOS representative.

Device

Device Recall EKOS Cart
  • Model / Serial
    Lot numbers: 030915 032615 040915 061515 071515 081715 103015 120715 010416 011816 022216 032116 052416
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY.
  • Product Description
    The EKOS cart has the catalog number 700-60101. || The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.
  • Manufacturer
    EKOS Corporation

Manufacturer

EKOS Corporation
  • Manufacturer Address
    EKOS Corporation, 11911 N Creek Pkwy S, Bothell WA 98011-8809
  • Manufacturer Parent Company (2017)
    Btg Plc
  • Source
    USFDA