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Recall Observatory FDA recall evidence

Device 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.

Z-0777-2013

September 24, 2012

Class II

Product summary

Firm
Winco Mfg., LLC
Event
Event 63651
Status
Terminated
Classification
Class II
Quantity
95 units (all models)
Official record key
device-enforcement:Z-0777-2013

Official wording

Reason: 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.

Code information: Model 5400. Serial numbers: 540100017, 540100020, 540100063, 540100160, 540100161, 540100162, 540100062, 540100103, 540100104, 540100105, and 540100106.

Distribution pattern: Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.