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Recall Observatory FDA recall evidence

Device product

XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

Z-1117-2014

September 06, 2013

Class II

Product summary

Firm
Winco Mfg., LLC
Event
Event 67377
Status
Terminated
Classification
Class II
Quantity
369 units (all models)
Official record key
device-enforcement:Z-1117-2014

Official wording

Reason: A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.

Code information: Model(s) 5291, 529S. Serial numbers: 529A003767, 529A003779, 529A003787, 529A003790, 529A003792 thru 529A003865, 529S100044 thru 529100050.

Distribution pattern: Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing assembly defect