Z-2401-2015 Class II Terminated
FDA device recall Z-2401-2015 was initiated by Winco Mfg., LLC on April 2, 2015 and is designated Class II. 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. The recall status is terminated (terminated December 14, 2016). Affected quantity: 27 chairs.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2015
- Initiation Date
- April 2, 2015
- Termination Date
- December 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 chairs
Product Description
Winco Elite Care Cliner w/Swing Away Arms X-Large - 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.
Distribution Pattern
Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
Code Information
Model Number: 6950, Serial Numbers: 695104466, 695104467, 695104445, 695104273, 695104460, 695104461, 695104462, 695104463, 695104464, 695104465, 695104450, 695104451, 695104452, 695104431, 695104438, 695104442, 695104444, 695104437, 695104438, 695104439, 695104440, 695104441, 695104442, 695104443, 695104444, 695104439 and 695104437 694A106091, 694A106092, 694A106093, 694A106094, 694A106095, 694A106096, 694A106097, 694A106098, 694A106099, 694A106034, 694A106035, 694A106036, 694A106037, 694A106038, 694A106039, 694A106040, 694A106041, 694A106042, 694A106043, 694A106044, 694A106045, 694A106087, 694A106088, 694A106089, 694A106058 and 694A106099