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Recall Observatory FDA recall evidence

Device product

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.

Z-0780-2013

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-0780-2013

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 6700, 6704 and 6710. Serial numbers: 670A100027, 670A100028, 670A100323, 670100082, 670100083, 670A100101, 670A100021, 670A100324, 670A100325, 670A100284, 670A100242, 670100005, 670100124, 670100125, 670100181, 670100182, 670100183, 670100184, 670100185, 670100186, 670100026, 670A100004, 670A100036, 670A100037, 670A100038, 670A100039, 670A100040, 670A100041, 670A100042, 670A100043, 670A100044, 670A100124, 670A100135, 670A100138, 670A100137, 670A100278, 670A100299, 670A100308, 670A100345, 670A100365, 670A100191, 670A100243, 670A100303, 670100027, 670100193, 670A100244, 670A100245, 670A100246, 670100018, 670100022, 670100021, 670100020, 670100175, 670100176, 670100177, 670100171, 670100187, 670100188, 670100189, and 670100190

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.