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U.S. Department of Health and Human Services

Class 2 Device Recall Hoyer Hydraulic Patient Lifters

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 Class 2 Device Recall Hoyer Hydraulic Patient Lifterssee related information
Date Initiated by FirmJanuary 06, 2006
Date PostedMay 25, 2006
Recall Status1 Terminated 3 on March 02, 2008
Recall NumberZ-0904-06
Recall Event ID 34153
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
ProductHoyer 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.
Code Information 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).
Recalling Firm/
Manufacturer		 Joerns Healthcare Inc.
5001 Joerns Dr
Stevens Point WI 54481-5040
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionA 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.
Quantity in Commerce32,109
DistributionNationwide, Canada, Asia, South America
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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