Recall Z-0780-2013— Winco Mfg., LLC
Class II · Terminated
Class II FDA medical device recall by Winco Mfg., LLC, initiated 2012-09-24, terminated 2013-05-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Winco Mfg., LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-24
- Terminated
- 2013-05-23
- Firm location
- Ocala, FL, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.