Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1115-2014Class II

CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed...

Champion Mfg, Inc. / initiated 2013-09-06 / Terminated / root cause: manufacturing process

Winco Mfg., LLC began a recall of CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray... on . FDA classified it as Class II and gives the reason as "A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1115-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Champion Mfg, Inc.
Product
CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.
Product code
INM Chair, With Casters
Reason for recall
A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Winco sent a Recliner Field Correction Notification letter dated September 11, 2013 to all affected consignees. The letter identified the product, the problem and action to be taken by the consignees. The consignees were instructed to complete and return the enclosed field correction response form back to Winco so they can send replacement mechanism(s) along with instructions on how to exchange the mechanism(s). Customers with questions were instructed to contact Customer Care at 800-237-3377 or email [email protected]. For questions regarding this recall call 352-854-2929, ext 130.
Quantity in commerce
369 units (all models)
Distribution
Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.
Product codes and lots
Model(s) 5251, 5261, 525S, 526S: Serial Numbers: 525108626 thru 525108774, 526100851 thru 526100919, 525S100070 thru 525S100081, 526S100037.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1115-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1114-2014Class IITerminatedVoluntary: Firm initiated
Z-1115-2014Class IITerminatedVoluntary: Firm initiated
Z-1116-2014Class IITerminatedVoluntary: Firm initiated
Z-1117-2014Class IITerminatedVoluntary: Firm initiated