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Recall Observatory FDA recall evidence

Device product

Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)

Z-2402-2015

April 02, 2015

Class II

Product summary

Firm
Winco Mfg., LLC
Event
Event 71496
Status
Terminated
Classification
Class II
Quantity
29 chairs
Official record key
device-enforcement:Z-2402-2015

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: 6240, Serial Numbers: 624100510, 624100511, 624100512, 624100513, 624100514, 624100515, 624100516, 624100519, 624100520, 624100521, 624100522, 624100523, 624100524, 624100525, 624100526, 624100527, 624100528, 624100529, 624100530, 624100531, 624100532, 624100533, 624100534, 624100535, 624100536, 624100537, 624100538, 624100539 and 624100540

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.