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Recall Observatory FDA recall evidence

Device product

Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

Z-2395-2015

April 02, 2015

Class II

Product summary

Firm
Winco Mfg., LLC
Event
Event 71496
Status
Terminated
Classification
Class II
Quantity
30 chairs
Official record key
device-enforcement:Z-2395-2015

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: 6550, Serial Numbers: 655A108119, 655A108120, 655A108121, 655A108122, 655A108123, 655A108124, 655A108125, 655A108126, 655A108127, 655A108128, 655A108129, 655A108130, 655A108131, 655A108132, 655A108133, 655A108134, 655A108135, 655A108136, 655A108137, 655A108138, 655A108139, 655A108140, 655A108141, 655A108142, 655A108143, 655A108144, 655A108145, 655A108146, 655A108147, and 655A108148

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.