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 Med

FDA device recall Z-0904-06 · posted 2006-05-25 · Terminated

Recall details

Recalling firm

Joerns Healthcare Inc.

Reason for recall

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 taken

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.

Root cause

Other

Status

Terminated

Product code

FSA

Quantity affected

32,109

Distribution

Nationwide, Canada, Asia, South America

Date initiated

2006-01-06

Date posted

2006-05-25

Date terminated

2008-03-02

Location

Stevens Point, WI