FDA-Device2013-02-13Class II

Designer Care Cliner 6700/6704/6710 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.

Winco Mfg., LLC
Hazard

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.

Sold states
Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.
Affected count
95 units (All models)
Manufactured in
5516 SW 1st Ln, N/A, Ocala, FL, United States
Products
Designer Care Cliner 6700/6704/6710 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0780-2013

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