| Class 2 Device Recall PREMIER CARE RECLINER 5570 | |
Date Initiated by Firm | September 06, 2013 |
Date Posted | February 26, 2014 |
Recall Status1 |
Terminated 3 on December 30, 2014 |
Recall Number | Z-1114-2014 |
Recall Event ID |
67377 |
Product Classification |
Chair, with casters - Product Code INM
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Product | PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell.
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. |
Code Information |
Model 5570. Serial numbers: 557A1100178 thru 557A100206. |
Recalling Firm/ Manufacturer |
Winco Mfg., LLC 5516 SW 1st Ln Ocala FL 34474-9307
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For Additional Information Contact | George J. Anello 352-854-2929 Ext. 130 |
Manufacturer 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. |
FDA Determined Cause 2 | Process control |
Action | Winco sent a Recliner Field Correction Notification letter dated September 11, 2013 to all affected consignees. The letter identified the product, the problem and action to be taken by the consignees. The consignees were instructed to complete and return the enclosed field correction response form back to Winco so they can send replacement mechanism(s) along with instructions on how to exchange the mechanism(s). Customers with questions were instructed to contact Customer Care at 800-237-3377 or email QA-RA@wincomfg.com.
For questions regarding this recall call 352-854-2929, ext 130. |
Quantity in Commerce | 369 units (all models) |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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