Recall of Device Recall Liko

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Liko, 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
    34463
  • Event Risk Class
    Class 2
  • Event Number
    Z-0790-06
  • Event Initiated Date
    2006-01-09
  • Event Date Posted
    2006-04-26
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2006-10-25
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Lift, Patient, Non-Ac-Powered - Product Code FSA
  • Reason
    The swivel adapter which is mounted directly above the slingbar's split center bolt could be removed and allow the slingbar to be improperly mounted directly into the aluminum link arm. this could cause an unsafe transfer. patient may fall.
  • Action
    Liko notified Distributors of the recall by letter on 1/9/06 via UPS and provided replacement Slingbars Version 2. Expanded Recall: On 6/20/06, Liko sent a 2nd recall letter expanding the recall to additonal serial numbers via Certified Mail.

Device

  • Model / Serial
    Serial Numbers: 7100102 - 7100104;   7100109  7100147 - 7100159  7100179 - 7100182  7100257 - 7100261  EXPANDED RECALL: Viking M:  Serial Numbers: 7100101 through Z-7100381
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    IL, MA, MO, PA, TN,
  • Product Description
    Liko Universal Slingbar 450 (aluminum) used with the Viking M Patient Lift
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Liko, Inc., 842 Upper Union Street, Suite 4, Franklin MA 02038
  • Source
    USFDA