Events

Recall of Device Recall Comfort Sling Plus Model 300

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom, 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
    57861
  • Event Risk Class
    Class 2
  • Event Number
    Z-1396-2011
  • Event Initiated Date
    2011-02-09
  • Event Date Posted
    2011-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97603
  • 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
    Non-AC-Powered Patient Lift - Product Code FSA
  • Reason
    Slings were improperly assembled and the loops that are used to support the sling when hung from a lift were too long, potentially putting the patient being lifted at risk of falling out.
  • Action
    The firm sent an URGENT MEDICAL DEVICE RECALL notice dated 02/09/2011 to Facility Risk Manager/Facility Administrators. The letter Identified the affected product, explained the recall situation, and asked firms to check their facility for the affected serial numbers. Consignees were asked to return the recalled products, and a replacement sling would be sent to them. Customers can contact Hill-Rom Technical Support at 800-445-3720, if they have any questions concerning this matter.

Device

Device Recall Comfort Sling Plus Model 300
  • Model / Serial
    Serial Numbers: A032220, A032221, A032222, A032223, A032224, A032227, A032228 and A032229.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Switzerland, Germany, Denmark, Finland, France, UK, Italy, Netherlands, Sweden, and Canada.
  • Product Description
    Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko a Hill-Rom Company. || Enables a comfortable sitting position and adapts to the patient without the need for individual adjustments when transferring a patient with a lift.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Manufacturer Address
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA