Events

Recall of Device Recall ARJO Carendo MultiPurpose Hygiene Chair

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

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
    52232
  • Event Risk Class
    Class 2
  • Event Number
    Z-1946-2009
  • Event Initiated Date
    2009-06-11
  • Event Date Posted
    2009-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82577
  • 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
    Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the care raiser seat is returned to its lowest position.
  • Action
    ArjoHuntleigh sent Urgent Device Field Correction letters dated June 11, 2009, along with the Urgent Field Safety Notice ID 090526AHE dated May 26, 2009, via UPS Ground delivery. Customers were informed of the affected device and were requested to complete the response form with new contact information and fax it back to ArjoHuntleigh at 630-567-5012 or 630-925-7969. For further questions, contact ArjoHuntleigh at 1-800-323-1245.

Device

Device Recall ARJO Carendo MultiPurpose Hygiene Chair
  • Model / Serial
    Model Number: BIB2003-01, all Serial Numbers below 0905000031.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ARJO Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden. || The equipment is intended for hygiene care, showering, and toileting of || hospital or nursing home residents under the supervision of trained || nursing staff and in accordance with the instructions outlined in the || Operating and Product Care Instructions.
  • Manufacturer
    ArjoHuntleigh

Manufacturer

ArjoHuntleigh
  • Manufacturer Address
    ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA