Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2400-2015

April 02, 2015

Class II

Product summary

Firm
Winco Mfg., LLC
Event
Event 71496
Status
Terminated
Classification
Class II
Quantity
32 chairs
Official record key
device-enforcement:Z-2400-2015

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: 6940, Serial Numbers: 694A106059, 694A106060, 694A106112, 654A105206, 654A105207, 694A106090, 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.