Class 2 Device Recall Junction Boxes

• Date Initiated by Firm: March 15, 2016
• Create Date: August 11, 2016
• Recall Status: Terminated on September 15, 2017
• Recall Number: Z-2402-2016
• Recall Event ID: 73577
• Product Classification: Bed, ac-powered adjustable hospital - Product Code FNL
• Product: Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
• Code Information: Model #'s:1104343 & 1104345
• Recalling Firm/ Manufacturer: Invacare Corporation; 1200 Taylor St; Elyria OH 44035-6248
• For Additional Information Contact: 440-329-6595
• Manufacturer Reason for Recall: The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Invacare sent an Urgent Medical Device Recall letter dated May 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call Invacares recall support line at (877) 413-6008, Monday  Friday, 8 a.m.  5 p.m. EST, for assistance.
• Quantity in Commerce: 1,011 units
• Distribution: US Nationwide Distribution including DC and PR. Internationally Canada.
• Total Product Life Cycle: TPLC Device Report

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.