Recall Z-1117-2014— Winco Mfg., LLC
Class II · Terminated
Class II FDA medical device recall by Winco Mfg., LLC, initiated 2013-09-06, terminated 2014-12-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Winco Mfg., LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-06
- Terminated
- 2014-12-30
- Firm location
- Ocala, FL, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.