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Recall Observatory FDA recall evidence

Device product

Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)

Z-2403-2015

April 02, 2015

Class II

Product summary

Firm
Winco Mfg., LLC
Event
Event 71496
Status
Terminated
Classification
Class II
Quantity
1 chairs
Official record key
device-enforcement:Z-2403-2015

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: 6980, Serial Numbers: 698101503

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.