Events

Recall of Lysus

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

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
    36517
  • Event Risk Class
    Class 2
  • Event Number
    Z-0195-2007
  • Event Initiated Date
    2006-10-12
  • Event Date Posted
    2006-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48787
  • 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
    infusion stand - Product Code FDX
  • Reason
    Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard.
  • Action
    The firm''s representatives will visit the consignees, apply the caution label and provide a letter, dated October 2, 2006, to the consignee. The letter states that the representative applied the caution label to the cart and reminds consignees if the UPS is removed and the cart is loaded with pumps and bags there is a potential for the cart to tip.

Device

Lysus
  • Model / Serial
    060113010-001, 060113010-002, 060113010-003, 060113010-004, 060113010-005, 060113010-006,  060113010-007, 060113010-008, 060113010-009,  060113010-010, 060113010-011, 060113010-012, 060113010-013, 060113010-014, 060113010-015,  060324025-001, 060324025-002  The additional carts do not contain any type of serial number.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Lysus Transport Stand (infusion stand), part number 4896-003
  • Manufacturer
    Ekos Corp

Manufacturer

Ekos Corp
  • Manufacturer Address
    Ekos Corp, 22030 - 20th Ave SE, Ste 101, Bothell WA 98021
  • Source
    USFDA