Events

Recall of Device Recall Hoyer Hydraulic Patient Lifters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Joerns Healthcare 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
    34153
  • Event Risk Class
    Class 2
  • Event Number
    Z-0904-06
  • Event Initiated Date
    2006-01-06
  • Event Date Posted
    2006-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43199
  • 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 field correction is being conducted on select models of hoyer patient lifts because of hydraulic jack problems that have resulted in patient injury. the possibility exists that the mounting stud located in the bottom of the hydraulic jack could become loose allowing the jack to disengage from the mast of the lift.
  • Action
    A Technical Service Bulletin was distributed along with an Urgent Medical Device Correction letter providing details for checking the mounting stud. UPDATE: Sunrise Medical sent a Second Notice Urgent Medical Device Correction letter, in follow-up to the January 2006 notice, to Dealer/Distributors starting 04/26/06. This Notice updates customers as to what Sunrise''s field correction will be for the Hoyer Model Hydraulic Patient Lifts. The Notice states that use of the affected devices should be discontinued until the lift has been inspected and repaired. Dealers/Distributors that have distributed the product are to notify the user to discontinue use, if possible. If the lift needs to be used then the Dealer/Distributor is to do an interim maintenance.

Device

Device Recall Hoyer Hydraulic Patient Lifters
  • Model / Serial
    Devices manufactured between July 1, 2001 and December 31, 2004. Model & Serial Number (S/N) Range: C-CB-L2 (S/N''s 0301L0905) , C-HLA (S/N''s: 0110L001 to 0412L0176, 0110J194 to 0204J0795, 0205H0043 to 412H0080 , C-HLA-2T (S/N''s 0206L1296 to 0409L2483, 0206H0945 to 0409H2570), C-HLA-2 (S/N''s 0107L0030 to 0412L0524, 0110J0195 to 0201J1338, 0202H0586 to 412H0082), HML400 (S/N''s 0110L061 to 0412L0127, 0110J098 to 0208J0162, 0112H555 to 0409H2418).
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Asia, South America
  • Product Description
    Hoyer Hydraulic Patient Lifters model C-CB-L2, C-HLA, C-HLA-2, HML-400, C-HLA-2T and C-HLA-1. Distributed by Sunrise Medical, Inc. 7477 East Dry Creek Parkway, Longmont, CO 80503 USA.
  • Manufacturer
    Joerns Healthcare Inc.

Manufacturer

Joerns Healthcare Inc.
  • Manufacturer Address
    Joerns Healthcare Inc., 5001 Joerns Dr, Stevens Point WI 54481-5040
  • Source
    USFDA