Events

Recall of Device Recall Carina Mobile Lifts

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

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
    78130
  • Event Risk Class
    Class 2
  • Event Number
    Z-0014-2018
  • Event Initiated Date
    2016-07-28
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158744
  • 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
    A limited amount of carina mobile lifts have been delivered with a too small locking pin. if a locking pin smaller than the correct size is mounted on the carina mobile lift, the locking pin is likely to cause increased wear on the plastic bushings. in case of continued use, these components may cause wear on the metal of the piston rod eye.
  • Action
    The firm initiated their recall by email on 07/28/2017. The firm directed the consignee to repair the units on site and destroy the affected parts.

Device

Device Recall Carina Mobile Lifts
  • Model / Serial
    a) Carina350EM, REF 6060011, Serial numbers: 661102000 - 661102160 b) Carina350EML, REF 60600012, Serial numbers: 661200500 - 661200584 c) Carina350EE, REF 60600009, Serial numbers: 660900500 -660900571
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    OH, PA, MD
  • Product Description
    Carina Mobile Lifts, Models: || a) Carina350EM, REF 6060011 || b) Carina350EML, REF 60600012 || c) Carina350EE, REF 60600009
  • Manufacturer
    Handicare AB

Manufacturer

Handicare AB
  • Manufacturer Address
    Handicare AB, Maskinvagen 17, Lulea Sweden
  • Manufacturer Parent Company (2017)
    Handicare Group Ab
  • Source
    USFDA