Events

Recall of Device Recall Carry bar

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ErgoSafe Products, LLC (DBA) Prism Medical.

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
    74488
  • Event Risk Class
    Class 2
  • Event Number
    Z-0728-2017
  • Event Initiated Date
    2016-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147755
  • 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 black plastic puck on the carry bar is breaking resulting in potential for patient harm.
  • Action
    The recalling firm sent field safety notices to their customers by mail on August 30, 2016. The notice instructed customers to inspect their carry bar to see if it used a black plastic puck. If it did, they were instructed to contact the recalling firm to receive a metal insert to install. If the puck is cracked or damaged, they can request a new, replacement carry bar at a discounted price. For further questions, please call (866) 891-6502.

Device

Device Recall Carry bar
  • Model / Serial
    There are no lot numbers, serial numbers, or UPC codes, only the model numbers.  Model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed US nationwide and to Canada, Japan, Australia, Thailand, Great Britain, and South Korea
  • Product Description
    Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.
  • Manufacturer
    ErgoSafe Products, LLC (DBA) Prism Medical

Manufacturer

ErgoSafe Products, LLC (DBA) Prism Medical
  • Manufacturer Address
    ErgoSafe Products, LLC (DBA) Prism Medical, 10888 Metro Ct, Maryland Heights MO 63043-2413
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    USFDA