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Recall Observatory FDA recall evidence

Device product

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

Z-2397-2015

April 02, 2015

Class II

Product summary

Firm
Winco Mfg., LLC
Event
Event 71496
Status
Terminated
Classification
Class II
Quantity
3 chairs
Official record key
device-enforcement:Z-2397-2015

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: 6570, Serial Numbers: 657A102238, 658A102236 and 657A102237

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.