Skip to content
Recall Observatory FDA recall evidence

Device product

Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

Z-2401-2015

April 02, 2015

Class II

Product summary

Firm
Winco Mfg., LLC
Event
Event 71496
Status
Terminated
Classification
Class II
Quantity
27 chairs
Official record key
device-enforcement:Z-2401-2015

Official wording

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.

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

Distribution pattern: Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.