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.
FDA Recall Z-0904-06 · Posted 2006-05-25
Recalling FirmJoerns Healthcare Inc.
Recall StatusTerminated
Product CodeFSA
Date Initiated2006-01-06
Date Terminated2008-03-02
Product Quantity32,109
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide, Canada, Asia, South America
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.