Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0777-2013Class II

PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi...

Champion Mfg, Inc. / initiated 2012-09-24 / Terminated / root cause: design

Winco Mfg., LLC began a recall of PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in... on . FDA classified it as Class II and gives the reason as "The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0777-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Champion Mfg, Inc.
Product
PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Product code
INM Chair, With Casters
Reason for recall
The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Root cause tag
design
FDA root cause
Component design/selection
Action
Winco sent a Chair Field Correction Notification dated September 24, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were instructed to forward the "Field Correction Form - REPAIR" form back to Winco and the firm would send a Winco Representative to the consignees' facility to correct the chairs in the field. Customers with questions were instructed to contact Winco at 800-237-3377 or email [email protected]. For questions regarding this recall call 352-854-2929, ext 110.
Quantity in commerce
95 units (all models)
Distribution
Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.
Product codes and lots
Model 5400.  Serial numbers: 540100017, 540100020, 540100063, 540100160, 540100161, 540100162, 540100062, 540100103, 540100104, 540100105, and 540100106.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0777-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0777-2013Class IITerminatedVoluntary: Firm initiated
Z-0778-2013Class IITerminatedVoluntary: Firm initiated
Z-0779-2013Class IITerminatedVoluntary: Firm initiated
Z-0780-2013Class IITerminatedVoluntary: Firm initiated