Recall Z-2400-2015— Winco Mfg., LLC
Class II · Terminated
Class II FDA medical device recall by Winco Mfg., LLC, initiated 2015-04-02, terminated 2016-12-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.. Reason: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards..
- Recalling firm
- Winco Mfg., LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-02
- Terminated
- 2016-12-14
- Firm location
- Ocala, FL, United States
Product description
Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Reason for recall
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Data sourced from openFDA. This site is unofficial and independent of the FDA.